SIERRASIL PROFESSIONAL REFERENCE GUIDE

SierraSil® is a unique mineral complex sourced from a pristine deposit located high on the eastern slopes of the US Sierra Mountains. It was first discovered by a gold prospector over thirty years ago who found something more valuable than gold – the natural gift of health. He observed wildlife grazing on a particular deposit and then tried the mineral on his domestic animals. Long story short, people who tried it often reported spectacular results. Our business was founded to commercialize this very special mineral deposit. Our simple goal is to help people with mild to chronic aches or soreness become healthier and more active. We strive to be ethical; to treat all people fairly and with respect; and to stand behind our ingredient (and products) with operating standards that meet or exceed regulatory requirements. Verifying safety and supporting health claims with quality first hand research is very important to us so we hope this Reference Guide is helpful to you. The Reference Guide highlights research on SierraSil and provides additional supporting documentation, some on third party sites. We welcome your feedback on any aspect of our business or our products at Info@SierraSil.com

SierraSil® is the trade name for a unique mineral complex sourced from a mineral deposit located high on the eastern slopes of the US Sierra Mountains. The late Dr. Hayden Murray, Professor Emeritus, Economic Geology, Clays, and Industrial Minerals, Indiana University, an expert in clay and related mineralogy, described the deposit as an alteration of a volcanic tuffaceous rock as a result of warm acid fluids which came from significant depths to the surface along fractures in the parent tuffaceous rock millions of years ago. “These hydrothermal fluids have altered the feldspar and zeolite minerals to montmorillonite (an absorbent clay), jarosite (a potassium iron sulphate) and hematite (an iron oxide). In addition to the above minerals, quartz (a pure silicon dioxide) and some partially altered feldspars are present as well.” Dr. Murray, who has studied deposits all over the world, said after conducting an X-Ray diffraction analysis “In my more than 50 years of mineral research, I have never seen a combination of minerals like this before”. The SierraSil® mineral structure may bind a variety of compounds by either absorbing or adsorbing them (collecting in a thin layer) to its molecular surface. However, testing with other supplement ingredients at UBC Food Sciences did not show material reductions in the activity of the other ingredients. Nevertheless, we recommend that SierraSil is not taken with critical medications.

Presented is a sample assay and bio-availability results. Results may vary from batch to batch and even within batch test results, due to natural variation and test variation. We use advanced mineralogical analysis techniques to analyze and identify the naturally occurring blend of silicate minerals in Sierrasil due to the absorptive nature of mineral structures. The bio-accessible amount represents the upper limit of potential bio-availability using the Unified Bioaccesibility Method (UBM) developed by the Bioaccessibility Research Group of Europe (BARGE) https:// www2.bgs.ac.uk/barge/ home.html#:~:text=BARGE%20(the%20Bioaccessibility%20Research%20Group%20of%20Europe) %20is%20a%20European,cadmium%20via%20the%20gastrointestinal%20tract. In the Research Section of the SierraSil Reference Guide is a study that shows the Bio-availability of tested heavy metals is a very small fraction of the bio-accessible amount and a study that shows SierraSil may pull certain heavy metals our of the body (chelating).

(a)Research Policy

Our policy is to share or publish research regardless of the findings. In other words, not to selectively publish results. We have made a significant investment in research to demonstrate both the safety and efficacy of the SierraSil® mineral complex. The research has been described as a “gold standard” for our industry and cited as an example of “excellence” by a Board member of the Natural Health Products Research Society (of Canada). The minerals have proven to be safe and effective in clinical and lab research as well as in a history of safe use, earning the confidence of experts such as a leading Rheumatologist who wrote that he “investigated the research.. and .. subsequently recommended (the minerals) to some of his patients with mild to moderate OA and/or RA. It is my observational experience that the minerals have been helpful in the majority of patients. Many of these patients have felt less discomfort and have been more able to resume exercise or enhance their mobility or other activity, improving outcomes and well-being. I note that the onset of such results has typically been within one or two weeks, surpassing my expectations” The research findings have had reasonably consistent results, verifying safety and efficacy, except perhaps surprisingly, that the heavy metal chelation effect doesn’t result in reduced availability of other nutritional supplements tested. The studies have been organized here based on relevance for efficacy, mechanism of actions and safety, not chronological order in which they were done.

(b) Human pilot study

TITLE:A pilot study to test the safety and efficacy of the mineral supplement SierraSil® in osteoarthritis of the knee.
OBJECTIVE:A pilot study to evaluate the safety and efficacy of SierraSil® in patients suffering from osteoarthritis of the knee. The 2003 study was conducted in a randomized fashion to administer patients diagnosed with moderate osteoarthritis of the knee with SierraSil® alone or SierraSil® plus a proprietary cat’s claw herbal extract.
METHODS:Baseline WOMAC scores were established after which the patients received one capsule three times daily of the treatment for 10 days. Post-treatment WOMAC scores and side effects were also recorded. The parameters of the study included WOMAC scores, OA clinical symptoms, stair climb ability, pain and stiffness reduction and quality of life.
RESULTS:100% of the subjects reported a significant improvement within one week of treatment on either SierraSil® alone or SierraSil® with the cat’s claw, with no concomitant medications (i.e. aspirin, acetaminophen) required or side effects reported.
CONCLUSION:This pilot study showed that SierraSil® alone or in combination with cat’s claw provided patients (with previously diagnosed osteoarthritis) benefits that were clinically measurable. This pilot study therefore warranted further investigation to determine the biological mechanism of action, the appropriate dosage and SierraSil®’s safety and efficacy in a larger scale clinical trial.

(c)Open Label Study KCK Synergize

Serving Guidelines for Joint Formula14™
RECOMMENDED DOSE: (ADULTS)Take 3 capsules once daily with water on an empty stomach. Persons with larger bodies or BMI of over 25 should consider taking 4 or 5 capsules per day, or a larger scoop of the powder.
DIRECTIONS FOR USE: For best results, take SierraSil® Joint Formula14™ (JF14) with water at least one hour before or after a meal or other beverages such as coffee, pop, tea, juice or milk. Take critical medications four hours before or after JF14. JF14 has detoxifying properties due to its clay-like silicate mineral structure, and it is strongly recommended to drink plenty of water for best results with SierraSil®. Increased water intake assists the body in flushing out toxins and heavy metals that are eliminated by the body when using SierraSil®.
SPECIAL CONDITIONS:Athletes and active adults participating in high-intensity exercise can take SierraSil® Joint Formula14™ 1 to 3 hours before activity to aid endurance and recovery and reduce delayed onset muscle soreness (post-exercise stiffness).
For those in weakened conditions, living with multiple pre-existing medical conditions or sensitive stomachs, start with one capsule, once per day and gradually work up to the recommended dose.
For those without sensitive stomachs, if results do not manifest within the first 7 days consider taking a loading dose. A loading dose is double the recommended daily dose for 7 days and can be taken to help increase results.
CAUTIONS AND WARNINGS
CAUTIONS:For a very small percentage of SierraSil® users, the detoxification process can cause some transient discomfort at first, known as a healing reaction, while the body adjusts to SierraSil® Joint Formula14™. A healing reaction is a temporary process that the body endures as it moves towards optimal balance and function (homeostasis). Symptoms of healing reactions vary, and may include headache, changes in bowel movements or a slight stiffening of the joints. These reactions are temporary and normally subside within 1 to 7 days of using SierraSil® Joint Formula14™. If the symptoms are too uncomfortable, lower the dose to 1 capsule or 667 mg daily and gradually increase to the recommended dose. To facilitate the detoxification process, it is critical to consume plenty of water (6+ glasses daily) while taking SierraSil® Joint Formula14™ to assist the body with eliminating toxins. Increased water intake will also reduce the risk of constipation while taking SierraSil.
WARNINGS:Pregnant or nursing women and persons with known medical conditions (such as cardiovascular diseases) should consult with their health care practitioner prior to using SierraSil® Joint Formula14™. SierraSil® Joint Formula14™ should be kept out of reach of children. SierraSil® has not been clinically tested for these population groups.
CONTRAINDICATIONS:SierraSil® Joint Formula14™ should not be taken at the same time of day as critical medications. The absorptive mineral complex in SierraSil® Joint Formula14™ may bind with medications due to its highly absorptive and adsorptive properties.

(d) Double blind, placebo controlled, OA study

TITLE: Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbo-mineral combination: A randomized controlled trial [ISRCTN38432711]
OBJECTIVE:This study was designed to determine if a natural mineral supplement, SierraSil®, alone and/or in combination with a cat’s claw herbal extract (Uncaria guianensis), Vincaria®, has therapeutic potential in mild to moderate osteoarthritis of the knee.
METHODS: 107 patients with mild to moderate osteoarthritis of the knee were randomly assigned to one of 4 groups in a double-blinded fashion: 1) high dose SierraSil® (3 g/day), 2) low dose SierraSil® (2 g/day), 3) low dose SierraSil® (2 g/day) + Vincaria® (100 mg/day) or 4) placebo, administered for 8 weeks. Primary efficacy variables were WOMAC scores. Secondary variables were: Visual Analog Score (VAS) for pain; consumption of rescue medication (paracetamol); and tolerability. Safety measures included vital signs and laboratory-based assays.
RESULTS: SierraSil® was able to produce significant improvement in WOMAC and VAS scores after 8 weeks (P < 0.001) either alone or in combination with Vincaria®. SierraSil® groups also produced a faster onset of benefits (at week 1, 2, and 4) in reference to baseline values when compared to placebo group. At 4 weeks, all the SierraSil groups displayed a 38–43% WOMAC improvement.
CONCLUSION:SierraSil® alone and in combination with cat’s claw extract improved joint health and function within 1–2 weeks of treatment. SierraSil® may offer an alternative therapy in subjects with joint pain and dysfunction. See PMID: 16242032 PMCID: PMC1276811 for the peer reviewed, published paper. Journal of Inflammation. J Inflamm (Lond). 2005;2:11.

(e)Double-blind, placebo controlled, cross-over Osteoarthritis study

Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee (11SOHS)
Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
TITLE:A randomized, double blind, placebo controlled cross over study to explore the efficacy and safety of SierraSil® Joint Formula14™ in adults with osteoarthritis of the knee.
OBJECTIVE:The primary objective of this study was to assess the efficacy of SierraSil® at 2 g/ day on the symptoms of osteoarthritis as assessed by WOMAC™ Pain subscale in Canadian subjects with osteoarthritis of the knee. Secondary objectives of the study were to determine changes in WOMAC™ osteoarthritis index physical function and stiffness subscales, SF-36 questionnaire scores, inflammatory markers such as hsCRP, TNF, and IL-6, onset of analgesia, amount of rescue medication used, safety parameters including vital signs, adverse events, and laboratory tests.
METHODS:In this randomized, double-blind, placebo controlled, cross over study, a total of 230 subjects were screened and 150 were found to be eligible to participate in the study. 75 subjects went on the SierraSil® treatment and the other 75 on placebo. Of the 150 subjects 25% were of healthy weight while 75% were large or obese by BMI measurement.
RESULTS:Subjects with a WOMAC™ Pain score between 16 and 33.3 mm at baseline showed a decreasing trend in Pain score from baseline to week 4. During the washout period, these subjects’ Pain scores increased suggesting efficacy of SierraSil®. Though subjects on placebo had an initial decrease in Pain score from baseline to week 2, an increase was seen by week 4. Subjects with a WOMAC™ Pain score between 66.7 and 100 mm at baseline showed a decreasing trend in Pain score from baseline to week 2 and plateaued by week 4 for both Placebo and SierraSil®. Within groups, subjects on SierraSil® demonstrated statistically significant improvements in SF-36 scores from baseline to week 4 for the domains: Physical Function, Role Limitation due to Physical Health, Vitality/Energy, Social Functioning, and Bodily Pain. Furthermore, subjects on SierraSil® showed statistically significant improvements in Total SF-36 scores, Total Physical Activity and Total Mental Health.
CONCLUSION: The study found that SierraSil® was effective in relieving pain associated with osteoarthritis as indicated by both WOMAC scores and SF-36 scores. SierraSil® was found in this study to be effective in temporary relief of joint pain, with more profound effect in subjects with normal body weight (BMI < 25.00 Kg/m2), suggesting that larger bodies would benefit from a larger dose than 2 g/day. This study was published in the following Dove Press Journal: Open Access Rheumatology: Research and Reviews 3, Oct 2014.

(f) Double Blind Placebo Controlled (Cross Over) Pilot Sport Study

TITLE: SierraSil as an ergogenic aid to performance in athletes.
OBJECTIVE:The purpose of this study was to examine whether Sierrasil® could improve anaerobic power in a group of well-trained athletes. A secondary purpose was to examine the effect of Sierrasil® on the severity of delayed onset muscle soreness (DOMS).
METHODS: 10 male, varsity football players were studied in a double-blind, cross-over design. The athletes (mean age= 22 years; height= 183.6 cm; weight = 90.3 kg) performed three Wingate cycle ergometer tests 5 minutes apart as a test of peak power, average power and fatigue index. They recorded DOMS on a 0-10 visual analogue scale (VAS) at 24, 48 and 72 hours post-exercise. Prior to exercise and 5 minutes following the last Wingate test, blood was taken for analysis of selected cytokines. The athletes were randomly assigned to Sierrasil® or placebo groups for three weeks and, following a three-week washout period, the experimental treatments were reversed. The products were dispensed according to the manufacturer’s recommendation.
RESULTS:All athletes completed the trial. Sierrasil® was well tolerated by highly trained male athletes. There were no adverse effects reported. Following Sierrasil® supplementation the peak power increased by 33.8 W (a 3% increase) and mean power by 6.7 W (a 1% increase). In the placebo group the peak power decreased by 11.2 W (-2.6%) and the mean power decreased by 17.2 W (-1%). DOMS values on the VAS were higher in the placebo group at 24, 48 and 72 hrs post-exercise (P= 3.2, 2.2, 1.3 vs. Sierrasil®= 2.5, 1.6, 0.6). There were no statistically significant changes in the performance measures between the two groups however (p>0.05). There were no significant changes in the cytokine measures following supplementation with either Sierrasil® or placebo.
CONCLUSION: The results showed that Sierrasil® is safe to use in highly trained athletes and resulted in improvements in anaerobic power and in reducing the level of DOMS post-exercise that the researchers, Dr. Don McKenzie and Dr. Jack Taunton describe as “sport significant”.

(g) N-1 Study

TITLE: N of 1 Study assessing soreness in a healthy adult male.
OBJECTIVE: Dr. James McCormack, UBC Title, offered to supervise a double blind, placebo controlled, multiple cross over N of 1 Study to assess the efficacy of SierraSil JF14 in a healthy SierrraSil customer, challenging placebo effects and speed of benefits.
METHODS: Eight bottles of a two week supply (4 each of placebo and treatment) were randomized on a double blind basis. The adult male patient kept a log of activity and noted soreness on a scale of 1 to 7 with definitions for each as established by Dr. McCormack. For example 1, represented no soreness to 7 which represented very severe soreness, cannot be ignored and markedly limits daily activity and often requires rest.
RESULTS: The patient soreness scores ranged from 1 (no soreness) to 4 (moderate soreness - cannot be ignored but does not influence my daily activities). The average soreness score (per bottle/2 week blocks) on treatment was 1.29 and the average soreness score on placebo was 2.13, a difference of 0.84 (placebo soreness 65% higher than treatment). All treatment score averages were lower than any of the placebo score averages. This is significant given the nature of the study, with what turned out to be 5 transitions from either placebo to treatment or treatment to placebo in the 16 week period, suggesting that the onset of benefits was rapid when on treatment, but there was similarly short ‘tail’ to the benefits.
CONCLUSIONS: For the patient in this double blind, placebo controlled multiple cross-over study, SierraSil JF14 significantly reduced soreness associated with activity such as running and other exercise.

(h) Mechanism of Action Study

TITLE: Suppression of Human Cartilage Degradation and Chondrocyte Activation by a Unique Mineral Supplement (SierraSil®) and a Cat’s Claw Extract, Vincaria®.
OBJECTIVE: This study investigated the hypothesis that the unique clay-based mineral supplement SierraSil® alone, and in combination with an extract of cat’s claw, Vincaria®, could limit human cartilage degradation-activated chondrocytes.
METHODS: The investigative model used was human cartilage tissue, obtained at the time of knee surgery. SierraSil® was subjected to neutral, alkali, and acid washes, followed by neutralization before addition to cartilage explants or cultured chondrocytes (0.05, 0.1, and 0.2 μg/ml). Vincaria®, an alkaloid depleted aqueous extract of cat’s claw (Uncaria Guianensis) was studied in combination with SierraSil® (2.5, 5 and 10 ng/ml).
RESULTS: Chondrocytes were activated with the addition of the inflammatory cytokine interleukin-1 (5 ng/ml). Measured outcomes were media nitrate/nitrite levels as an index of nitric oxide production, and media glycosaminoglycan (GAG) concentrations as an index of matrix breakdown. Following neutral or alkali washes, a small reduction in GAG release was observed with neutral extracts (p<0.05). The combination of SierraSil® + Vincaria® significantly reduced both GAG and nitric oxide release under these conditions. Following an acid wash to mimic passage of the material through the stomach, SierraSil® alone significantly reduced IL-1-induced GAG release by 68–73% (p<0.01) and SierraSil® + Vincaria® by 58–77% (p<0.01). Production of NO by human chondrocytes was also reduced by acid-washed SierraSil® alone (p<0.05) and was more pronounced with the SierraSil® + Vincaria® combination (p<0.01). IL-1-induced nitric oxide production and GAG release is known to reflect the activation of inducible pathways (inducible nitric oxide synthase and matrix metalloproteases).
CONCLUSION: The attenuation of these events suggests that SierraSil alone or in this herbo-mineral combination limits cartilage destruction by curtailing these transcriptional events in chondrocytes. Results suggest that this nutraceutical-based therapeutic agent may offer a new approach to limiting joint destruction and immobility associated with arthritis.

(i)Radiation protection study

TITLE: Effect of SierraSil® hydrothermal mineral complex (HMC317) on [3H-Methyl] Thymidine uptake in human liver (THLE-2), human normal skin (NHEM) and human melanoma skin cells (A375).
OBJECTIVE: This study was to investigate the effect of SierraSil® on [3H-Methyl] Thymidine uptake as a measure of radiation absorption by various human cells.
METHODS: An in vitro assay was designed to measure the uptake of [3H-Methyl] Thymidine by three human cell lines: human liver (THLE-2), human normal skin (NHEM) and human melanoma skin cells (A375). SierraSil® powder dissolved in complete growth media provided ~2.4% soluble solids in the filtrate that were used in the assay. [3H-Methyl] Thymidine at concentrations of 0.5, 0.1 and 0.05 μCi were tested at 24, 48 and 72 hours after incubation with the test product.
RESULTS: After 24 hours of incubation there was a significant decrease in the amount of radiation detected in THLE-2 cells exposed to all three concentrations of [3H-Methyl] Thymidine in the presence of SierraSil® compared to control liver cells. After 24 hours of incubation there was a significant decrease in the amount of radiation detected in NHEM cells exposed to 0.05 μCi of [3H-Methyl] Thymidine in the presence of SierraSil® compared to control normal skin cells. After 72 hours of incubation, there was a significant decrease in the amount of radiation detected in A375 cells exposed to 0.05 μCi of [3H-Methyl] Thymidine in the presence of SierraSil® compared to control melanoma cells.
CONCLUSION: Analysis of the data showed that cells cultured in the presence of SierraSil® powder demonstrated lower incorporation of [3H-Methyl] Thymidine compared to cells cultured in the absence of SierraSil®. The study also established that the absorption of radiation in the form of [3H-Methyl] Thymidine is dose, time and cell type dependent.

(j) Toxicology and chelation study

TITLE: The Toxicology and Potential Chelating Effect of SierraSil®
OBJECTIVE:A pilot study led by Dr. James Lavalle designed to assess potential for accumulation of toxic minerals in humans and to reveal if SierraSil® has a chelating effect on toxic metal accumulation.
METHODS:12 subjects entered the study designed to examine the effects of SierraSil® on 16 potentially toxic metals and 19 essential elements over a 6-month period.
RESULTS:7 subjects completed the study. The data reveals that arsenic levels appear to rise from T0 to T3 (and from T0 to T6). However, they declined from T3 to T6, although this change was not statistically significant. All the measurements for arsenic levels remained within the normal reference range. If the arsenic in SierraSil® was bioaccessible, then the levels should have continued to rise. As a natural chelating agent, ingestion of SierraSil® caused a 56.9% decrease in lead between T0 and T6, and a 62.7% decrease between T3 and T6, both of which were statistically significant at the 5% level.
CONCLUSION: It appears that daily ingestion of SierraSil® at 4 g/day may have a profound effect on the lowering of lead levels and may have the potential to lower the risk of the adverse health effects associated with lead exposure.

(k) Long term user medical analysis

TITLE: Long term user medical analysis by Dundarave Medical Clinic, West Vancouver, BC, Canada.
OBJECTIVE:: This laboratory analysis was conducted to examine the blood chemistry and other health indicators of patients who have been taking SierraSil® over a long period of time (2 to 5 years).
METHODS:A full laboratory analysis was conducted on 9 patients with a mean age of 60.1 years with the range of 41–85 years old. The average use of SierraSil® in this study was 2–4 capsules per day for a minimum of 2 years. Haematology, general blood chemistry, adrenal function and serum proteins were included in the laboratory analysis.
RESULTS:Lab analysis showed that these patients have normal to low-normal profiles of parameters described above, for instance, the cortisol is averaging 350.38 nmol/L when the normal range is 140 – 690 nmol/L, showing that adrenal function of the 9 patients was healthy. A more important and more relevant testing was the C - reactive protein (CRP) as it relates to inflammatory processes in the body. The average CRP level of the 9 patients was 2.2 mg/L where the normal range is < 5.0 mg/L. this again shows that SierraSil® may have anti- inflammatory properties in patients suffering from osteoarthritis; however OA markers were not included in this lab analysis.
CONCLUSION: Patients who are on long term use of SierraSil® were found to have a healthy and normal biochemistry profile when compared to the established normal ranges.

(l)Long-term user heavy metal analysis

(m)Bacterial Reverse Mutation (AMES) test

TITLE: Review of SierraSil® Bacterial Reverse Mutation (AMES) Test.
OBJECTIVE: SierraSil® mineral was tested in bacterial reverse mutation assay for its potential to induce point mutations in S. typhimurium strains TA-98, TA-100, TA-1535, TA-1537 and E. coli strain WP2 uvrA. The experimental design followed the OECD guideline for testing of chemicals– 471, bacterial reverse meutation test (1997).
METHODS: The powder was stored at room temperature during the study. A large portion of it was insoluble in common solvents that were compatible with the assay. The insoluble material precipitated in the testing agar plates and interfered with colony counting. In the main studies, the sample was prepared in DMSO and water by shaking at 45oC for two days. Exposure concentrations were expressed in “mg eq. per plate”. “Mg eq.” represented the number of mg from which the extract was prepared. DMSO extracted SierraSil® was tested in a plate incorporation assay; water extract, in pre-incubation assay.
RESULTS: Bacterial toxicity was observed in all strains exposed to DMSO extracts with S9. This limited the maximum exposure concentrations to 2.07 mg eq. per plate for this part of the study. With the addition of S9, exposure to as high as 56.00 mg eq. per plate of DMSO extract did not cause obvious toxicity. Water extract was largely non-toxic with or without S9. Maximum extractable concentration was in this case included in the exposure concentrations that ranged from 0.55 to 44.40 mg eq. per plate. All tester strains showed only background level of reversion at any exposure concentration with either extract. The observed means for triplicate plates of each concentration was largely within the range of the means ± 2 SD of the corresponding solvent controls.
CONCLUSION: It was concluded that the mineral was not mutagenic to S. typhimurium strains TA-98, TA-100, TA-1535, TA-1537 and E. coli strain WP2 uvrA under the test conditions.

(n)Acute oral Toxicity Test (AOT)

TITLE: Review of SierraSil® acute oral toxicity test.
ABSTRACT: The acute oral toxicity study completed on SierraSil® found that the acute oral LD50 of SierraSil® to be in excess of 2000.0 mg/Kg body weight. No effects of toxicity or mortality were observed at any point during the 14 days of testing. The animals gained weight during the test. Post-testing examination showed no gross pathological findings in any of the five rats.

(o)SubAcute Oral Toxicity Test (OECD Protocol 408)

TITLE: Repeated dose 90-day oral toxicity study with 28-day recovery period of SierraSil® in Sprague Dawley rats (OECD Protocol 408).
OBJECTIVE: The study was to assess the toxicological profile of SierraSil® when rats are exposed daily to the test article over a period of 90 days, by oral gavage.
METHODS: Groups of 10 male and 10 female Sprague Dawley rats were administered SierraSil® by oral gavage daily at the doses of 100 mg, 550 mg or 1000 mg per kg body weight for 90 days and were sacrificed on day 91 to evaluate its toxicity. Concurrent control group receiving vehicle at 10 ml/kg was also maintained. Additionally, groups of 5 rats per sex receiving vehicle at 10 ml/kg and the test article at 1000 mg/kg levels were further observed for a period of 28 days following 90 day exposure, for assessment of reversibility, persistence or delayed occurrence of toxicity
RESULTS: There was no treatment related mortality among rats exposed to SierraSil® at all three doses. No findings indicative of neurotoxic potential of the treatment were reported. Body weight gain by treatment group was found to be comparable to that by the control group. Food consumption was also comparable between the treatment group and control group. Haematology, clinical chemistry, urinalysis, organ weights, gross pathology and histopathology all revealed no significant difference between treatment group and placebo group.
CONCLUSION: Based on the findings of this study, the no-observed-adverse-effect-level (NOAEL) of SierraSil® in Sprague Dawley rats, following oral administration for 90 days was found to be more than 1000 mg/kg body weight (equivalent to about 35 times the recommended dosage/serving).

(p)SubAcute Oral Toxicity Test (SAOT) Liver Analysis

TITLE: Repeated dose 90-day oral toxicity study with 28-day recovery period of SierraSil® in Sprague Dawley rats.
OBJECTIVE: The study was to address body weight and liver chemistry analysis of rats that had been fed SierraSil® over a period of 90 days by oral gavage.
METHODS: In the same study as described previously, liver samples for rats treated with SierraSil® were prepared and analyzed as it is a safe assumption that hepatic metal content is reflective of levels in other tissues of the animal.
RESULTS: Total iron content of the liver, total lead content of the liver, total arsenic content of the liver and total aluminum content of the liver were analyzed in 10 rats from the control group and 10 rats from the high dose group (1000 mg/kg body weight of SierraSil®). The weight of the liver was also compared between control and high dose groups. No statistically significant difference was found in any of the above liver analyses.
CONCLUSION: Even at very high dosages there was no accumulation of metals tested in the liver, even a trend to lower lead levels.

(q)Bio-accesibility Dissolution Test (USP711)

TITLE: Dissolution Testing of SierraSil® USP <711>
OBJECTIVE: This experiment is conducted to determine if metals from the SierraSil® product are bioaccessible following digestion with simulated gastric and intestinal fluids at physiological temperature (37°C).
METHODS: The test protocol follows the Dissolution method <711> described in USP 24 NF-19. The experiment was conducted in a water bath at 37 ± 2°C. All materials were cleaned and rinsed according to standard procedure. Both digestive solutions – gastric fluid and intestinal fluid – were prepared according to the USP 24 NF-19 method. The bioaccessibility of metals in the test sample was estimated using the equation: [concentration of a given metal determined in the chime] / [concentration of the given metal determined in the SierraSil® sample before digestion x 100%].
RESULTS: The mean concentration of mercury was 0.213 ± 0.004 μg/0.667g. However, the mean bioaccessibility of mercury was 1.4%. The concentration of lead in the test sample was 4.3 ± 0.04 μg/0.667g, while the bioaccessibility was 0%. The bioaccessibility of cadmium was 108%, however, the concentration of cadmium in the test sample, 0.03 ± 0.002 μg/0.667g, was very close to the limit of detection (0.02 μg/0.667g).
CONCLUSION: The estimated daily intake for elements of potential concern, based on an expected consumption of three 0.667g-capsules per day (containing a total of 2g of SierraSil®), showed that the concentrations of mercury, lead and cadmium in the sample were extremely low and came well within the limits of Health Canada regulations.

(r)In-vitro Bio-accessibility and Bio-availability study

TITLE:In-vitro bioaccessibility and bioavailability of heavy metals in mineral clay complex used in natural health products
OBJECTIVE:This study evaluates in vitro bioaccessibility and bioavailability of Arsenic, Cadmium, and Lead in mineral clay samples from the Sierra Mountains using the UBM method and the Caco-2 permeability assay, respectively.
METHODS:Clay samples were air-dried, then sieved and screened to guarantee only particles smaller than 250 μm. Ten clay samples were digested and analyzed using synthetic digestive fluids to simulate human digestion to determine bioaccessibility of metals present in clay. Sodium arsenate dibasic heptahydrate (As), cadmium acetate (Cd), lead acetate trihydrate (Pb) were used as references to test the bioavailability of free minerals.The bioavailability f the heavy metals was analyzed using Caco-2 cell culture.
RESULTS:Following the UBM-gastric digestion As and Pb were lower than the Cd and decreased more after the UMB-gastrointesinal assay. The initial heavy metals ranged from 3.8–17 ppm for As, 0.024–0.061ppm for Cd, and 5.8–20 ppm Pb. However, the bioavailability was reduced to non-detectable values of As, <0.007ppm of Cd, and <0.1ppm of Pb using the Caco-2 cell permeability assay.
CONCLUSION:Based on the combined bioaccessibility and bioavailability results, consumption of these mineral clays poses low probability of risk if an amount of 11-15mg per lb body weight recommendation is followed

(s)Tart Cherry and SierraSil In-vitro Bio-accessibility and Bio-availability study

TITLE:In-vitro bioaccessibility of tart cherry anthocyanins in a health supplement mix containing mineral clay
OBJECTIVE:This study was conducted to determine if the presence of a cationic based mineral clay will inhibit the bioaccesibility of anthocyanin and its antioxidant capacity.
METHODS:Clay mineral mixtures were disaggregated and screened to remove particles greater than 250 μm. Mineral clay was mixed with tart cherry extract. Synthetic digestive fluids were used for the 2-step in vitro digestion method used to simulate gastric and gastriuntestinal digestions of the clay samples. The antioxidant capacities of fresh and digested extracts were determined using the oxygen radical absorption capacity assay (ORAC).
RESULTS:Based on the study results, after gastric digestion, tart cherry anthocyanins are stable and bioaccessible, but after gastrointestinal digestion they were largely transformed and degraded by upwards of 70%. The total antioxidant capacity of the tart cherry extract increased almost 2-fold after GI digestion. In the presence of the cationic-based mineral clay, anthocyanin recovery displayed no significant difference when compared with the control, thus the cationic- based mineral clay was not a factor in reducing anthocyanin bioaccessibility, or associated antioxidant capacity.
CONCLUSION:The presence of the cationic-based mineral clay was not a factor in reducing anthocyanin bioaccessibility, or associated antioxidant capacity due to no significant difference between anthocyanin recovery when present with the mineral clay formulation when compared to control.

(t)Glucosamine and SierraSil In-vitro Bio-accessibility and Bio-availability study

TITLE:Effect of a clay-mineral matrix on in vitro bioaccessibility and bioavailability of glucosamine.
OBJECTIVE:The purpose of the present study was to determine the in-vitro bioaccessibility and bioavailability of glucosamine sulfate using a health supplement that consisted of a mineral base matrix.
METHODS:Glucosamine sulfate was analyzed using AOAC Official Method 2005.01. For the in vitro bioaccessibility measurement, synthetic gastric and gastrointestinal fluids were prepared. The in vitro bioavailability of heavy metal was analyzed using Caco-2 cell culture.
RESULTS:Results showed that the fraction of ingested glucosamine that can potentially be made available for absorption was very close to 100%. Following gastric digestion different mineral clay-glucosamine samples exhibited bioaccessibility that ranges from 92.3-105.2% and 87.1- 97.2% after gastrointestinal digestion. The bioavailability of the glucosamine obtained from the mineral clay matrix varied between 18-28.8%, which is similar to the absorption of pure glucosamine sulfate which was found to be 22%.
CONCLUSION:The results confirmed that glucosamine sulfate remains stable during gastric and gastrointestinal phase digestion and retains high bioaccessibility when present in a clay mineral mix.

(u) Multi-Disciplinary Discussion on Joint Health (see attached)

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SierraSil® is certified by HFL Sport Science to be a safe product that is free from banned substances and meets the strict requirements of the World Anti-Doping Agency (WADA), and has been awarded Informed Choice certification. HFL Sport Science has over 40 years’ continuous experience in the science of sports doping control. This includes experience testing within the framework of the World Anti-Doping Agency (WADA) and testing human and animal food supplements for substances prohibited in sports. Their highly qualified team of scientists delivers both operational screening services and innovative research into prohibited substance detection
Together, the studies, testing and certification performed by HFL provide sound evidence of SierraSil®’s safety for use by the general public as well as those whose professions require certification of absence of banned substances. Please refer to the attached Informed Choice certificate.
  • Informed Choice
  • Health Canada
    •
  • JF14 capsules NPN
  • JF 14 powder NPN
  • JFC3 NPN
  • JFG5 NPN
  • PRTS NPN
  • National Animal Supplement Council
  • North American Trademark Registrations
  • Canada 1575472 and 1783578
  • USA
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    • List of our products and Durwell Joints&Mobility

    Joint Formula (51 Capsules)

    Joint Formula (180 Capsules)

    Joint Formula Curcumin (90 Capsules)

    Joint Formula Curcumin (180 Capsules)

    Joint Formula Dietary Supplement

    Joint Formula Glucosamine (120 Capsules)

    Joint Formula- Joint Pain Relief (90 Capsules)

    Joint Formula Powder (240 g)

    WHO IS SIERRASIL® JOINT FORMULA 14™ INTENDED FOR?
    SierraSil® is recommended for adults suffering from sore joints or stiffness. Particular benefits are for the following:
  • Athletes seeking improved peak power and reduced delayed onset soreness (DOMS).
  • Boomers seeking to better enjoy activity with reduced joint discomfort and stiffness.
  • Seniors seeking to regain or maintain independence with increased agility in fingers and reduced discomfort and stiffness in all joints including shoulders, knees, hips, and reduced ‘morning stiffness’ throughout the body
    • SierraSil® may also aid digestive health, reduce acid reflux and support faster recovery of certain injuries such as rotator cuff and carpal tunnel. However, these are anecdotal observations and have not yet been studied clinically.
    SierraSil® is not recommended for people on numerous medications, as SierraSil®’s detoxifying properties may partially absorb these medications. It is also not recommended for pregnant or nursing women as it has not been clinically tested in this population.
    HOW DOES SIERRASIL® JOINT FORMULA 14™ WORK? We know from published in vitro research at Case Western Reserve University that SierraSil® moderates inflammation and curtails cartilage breakdown. These results are consistent with those of the human clinical studies. SierraSil® may also help to detoxify the body, an inference that can be reasoned based on the studies completed.
    WILL SIERRASIL® JOINT FORMULA 14™ HELP WITH ARTHRITIC SYMPTOMS? Clinical and anecdotal evidence confirms that SierraSil® Joint Formula14™ is likely to provide noticeable benefits for symptoms of arthritis within two weeks. SierraSil® Joint Formula14™ reduces inflammation, down-regulates specific enzymes involved in the inflammatory process and reduces cartilage breakdown which are factors leading to the development of arthritic symptoms. Human studies confirm these findings for osteoarthritis, showing that SierraSil® Joint Formula14™ significantly improves joint health and function within a 2-week period. In addition, many consumers report significantly reducing their use of pain medications such as NSAIDs while using SierraSil®. SierraSil® was awarded United States patents in 2009 and in 2011 as a nutritional supplement for osteoarthritis.
    CAN PATIENTS WITH SENSITIVE STOMACHS TAKE SIERRASIL® JOINT FORMULA 14™? In case of sensitive stomach, patients should start with 1 capsule per day, gradually increasing the number of capsules to the recommended dose over 14 days. People with GI conditions such as acid reflux, gas, bloating, constipation, leaky gut syndrome, IBD, colitis, diverticulitis, IBS and Crohn’s disease have been reporting benefits from taking SierraSil® Joint Formula14™. The mineral structure of SierraSil® Joint Formula14™ has detoxifying properties that may help to cleanse and promote a healthy digestive system and possibly protect the stomach lining
    CAN PATIENTS TAKE SIERRASIL® JOINT FORMULA 14™ WHILE ON MEDICATION OR OTHER NATURAL SUPPLEMENTS? It is recommended for patients to discuss their supplements and medications with medical advisors prior to using any new products including SierraSil® Joint Formula14™. SierraSil® Joint Formula14™ is a pure natural mineral that has been extensively tested for safety and is NOT known to have adverse effects. Please refer to the dosage guidelines. Patients should take critical medications at least 4 hours before or after SierraSil® Joint Formula14™. Contact customer service at 1-877-743-7720 or info@sierrasil.com if you have questions on the best time of day to take SierraSil® Joint Formula14™
    IS SIERRASIL® JOINT FORMULA 14™ BENEFICIAL AND SAFE FOR ATHLETES? Yes. SierraSil® Joint Formula14™ is routinely tested and is free of banned substances as listed by the World Anti-Doping Agency (WADA). Testing is done independently and certified by Informed Choice (www.informed-choice.org). SierraSil® Joint Formula14™ eases joint and muscle aches, reduces stiffness and helps prevent cartilage breakdown associated with exercise and movement. SierraSil® has also been endorsed by numerous amateur and professional athletes. A pilot double blind, cross-over, placebo controlled study with elite athletes suggests that SierrSil Joint Formula 14 may offer "sport significant" increased peak power and reduced Delayed Onset Muscle Soreness (DOMS)
    IS SIERRASIL® JOINT FORMULA 14™ SUITABLE FOR MOST DIETARY REQUIREMENTS OR PREFERENCES? SierraSil® Joint Formula14™ is 100% vegetarian and vegan compatible, and all capsules are VegiCaps™. SierraSil® Joint Formula14™ is GMO free and contains no sugar, starch, salt, wheat, gluten, corn, flavoring* or preservatives. The SierraSil® mineral ingredient is also BC Kosher certified. *with the exception of lemon-lime powder.
    WHY IS THERE AN IRON WARNING ON THE LABEL FOR SIERRASIL® JOINT FORMULA 14™? There is approximately 120 mg of total iron content per serving of SierraSil® Joint Formula14™; however studies indicate that only about 1.2 mg of iron or approximately 7% of the recommended daily iron intake is bioaccessible. There is a required warning on the labels of all ingested products to protect against young children (under the age of 6) accidentally consuming an entire bottle of iron-containing supplements and possibly experiencing harmful side effects. SierraSil® Joint Formula14™ has been tested at up to 70 times the recommended dosage in accordance with standardized procedures and shown to have no indications of toxicity.
    IS THERE ALUMINUM IN SIERRASIL®? Yes, there is. The bioaccessible amount is less than 10mg per daily dose. This is a fraction of the aluminum content of commonly consumed products such as antacids, baked goods and cheeses. Most of the aluminum in SierraSil® is tightly bound to the silicate fraction that passes through the body with no chance for absorption. Furthermore there is evidence that even at extended levels of 35 times the recommended SierraSil® dosage or serving that there is no accumulation of aluminum. Aluminum is the third most abundant element on earth and is part of most of what we eat.
    HOW IS SIERRASIL® JOINT FORMULA 14™ DIFFERENT FROM OTHER NATURAL JOINT HEALTH PRODUCTS? Most natural health products provide ingredients that are building blocks of human cartilage or joint structure. These include glucosamine, condroitin, fatty acids, hyaluronic acids, collagen and so forth. In theory these products supplement the body’s natural regenerative process. SierraSil® and some herbs are among the joint health ingredients that calm the underlying inflammation. SierraSil® can be complimentary to other ingredients or products but the collection of SierraSil® attributes make it stand out. These attributes include:
  • SierraSil, when taken as directed, has very high efficacy rates – most patients will feel results
  • SierraSil usually provides reductions in aches or stiffness quickly. Often within a few days but guaranteed within 14 days (or money back).
  • SierraSil calms the underlying inflammation, giving the body a better chance to heal itself.
  • SierraSil appears to assist peak power and reduce delayed onset muscle soreness
  • SierraSil may have additional benefits such as detoxifying.
  • SierraSil is suitable for most dietary types, including diabetics, vegans and celiac sensitivities.
  • SierraSil is mineral based, requiring no pesticides, fertilizers or solvents in its production
  • SierraSil is suitable for those mindful of radius sourcing, as it is one of the few joint health products entirely sourced and produced in North America.
    • HOW SHOULD SIERRASIL® JOINT FORMULA 14™ BE TAKEN?
    4 Keys to note:
  • Take away from critical medications.
  • Drink plenty of water.
  • Larger people benefit from increasing dosage.
  • Best results when taken away from food.
    • HOW LONG HAS SIERRASIL® BEEN MARKETED TO CONSUMERS? SierraSil® has been marketed since 2004 (following years of "non-commercial" use). There have been millions of servings of SierraSil®.
    HOW DOES SIERRASIL ENSURE CONSISTENCY FROM BATCH TO BATCH? Product consistency is an important part of Sierrasil Health Inc’s commitment to Quality. There are 4 levels of testing that are carried out from the mining of the raw material to the final release of the finished product.
    Level 1 Testing: Before Sierrasil Health Inc mines the raw hydrothermal mineral complex that is to be used in the SierraSil products, we confirm the consistency and quality of the material by testing samples obtained from the mine. The testing includes electronic and physical assays, and X-ray diffraction, to confirm that the mineral composition matches the SierraSil mineral complex specifications. There is also microbial contamination testing, to ensure the purity of the material. Only when our Mine Operations group is assured of the quality and consistency of the sampled material by verifying that test results meet the established specifications, will the mining commence.
    Level 2 Testing: Before the raw material can be used in the manufacture of finished products, it is milled using standardized procedures. To ensure that these specifications are met, samples from each batch of the milled material are tested for composition, bioaccessibility, microbial contamination, heavy metal impurities, particle size and density. The results must meet the established specifications before the milled batches can be approved by Sierrasil Health Inc’s Quality Assurance group for use in the finished product.
    Level 3 Testing: Once the raw material is approved for use by Sierrasil Health Inc’s Quality Assurance group, it is shipped to our GMP-certified and quality-approved contract manufacturers where the material is inspected and re-tested against their internal quality specifications. Upon approval by their Quality Assurance group, the material is then used to make the SierraSil bulk products. More controls are in place during the manufacturing and packaging processes of the bulk and finished products. Quality-approved master production instructions are in place for the manufacture and packaging of the products and each batch of SierraSil products are made according to these standardized instructions. This is to ensure that product consistency is maintained from batch to batch, meeting our quality specifications and the label claims for which they have been approved by regulatory authorities. After the bulk product is manufactured, it is tested. Only if all results meet the specifications will the bulk product be packaged into the final packaging.
    Level 4 Testing: At the stage where the bulk product is packaged into final packaging, another round of microbial testing is conducted to provide verification that no possible microbial contamination occurred during the packaging process. Once this is confirmed with satisfactory test results, the product can then be released from our manufacturers
    However, before Sierrasil Health Inc approves the product for sale to the public, our Quality Assurance Group reviews all documentation from the manufacturers and confirms that all required testing has been completed and no issues arose during the manufacture and packaging of the products. With the satisfaction that the finished products are made to the established procedures and meet all of Sierrasil Health Inc’s quality standards, SierraSil Health Inc’s Quality Assurance will approve the finished product batch to be made available for sale.
    IS OR CAN SIERRASIL BE EXPOSED TO UNDESIRABLE SOLVENTS, PESTICIDES OR OTHER UNINTENDED INGREDIENTS FROM SOURCE TO FINISHED PRODUCT?
    There are no pesticides, fertilizers or solvents used in the production of SierraSil. SierraSil is mined in a remote area a substantial distance away from industrial or agricultural activity and free from any airborne or ground sourced pollutants. SierraSil is then mined, handled and processed with operational procedures to keep it clean and pure. SierraSil is thoroughly tested and third party verified.
    WHAT OTHER CLINICAL STUDIES IN SIERRASIL HEALTH INC. UNDERTAKING?
    SierraSil has recently entered into a 24 month research agreement with UBC Food Sciences department. The next phase of research will include mechanism of action research to better understand the bioaccesibility of the minerals, how SierraSil passes through the digestive system, how it interacts with other medications and supplements and some preliminary research on how SierraSil affects inflammation of the digestive tract.
    It is known that SierraSil can inhibit joint inflammation, however, there is no current information on its effectiveness to inhibit intestinal inflammation. We have a number of customers who have reported better digestion and relief from IBS and Chrohn's symptoms and we look forward to learning more about this through what's known as an in vitro inflamed intestinal cell model to investigate the effectiveness.
    The bioaccesibility and drug interaction component of the research are to further understand the pharmacokinetics of SierraSil. We know through previous research that SierraSil is absolutely safe for long term use and this research will further add to that. We currently advise customers to take SierraSil away from medication because of the detoxifying properties of SierraSil, and with an abundance of caution advise that 4 hours should be allowed both before and after taking SierraSil. The research will help clarify if the 4 hour window is necessary and will help us better understand the chelating effect of the mineral. The method used is known as Caco-2 monolayer to investigate the effects of SierraSil on the bioavailability of drugs and natural health products.

    Absorptive Minerals – Mechanisms behind Clay’s Medicinal Uses
    By: Sarah Holvik, B.Sc. Nutritional Science
    People and animals alike have used natural earth minerals for numerous medicinal and health-promoting applications throughout history. Minerals in the form of clays and soils have been consumed orally, called geophagy, as well as topically for medicinal and cosmetic purposes. Although at first glance this behavior seems perplexing, science has revealed several possible theories behind this practice. The theory behind geophagy, the deliberate consumption of non-food earth substances such as edible clays, soils and chalk, is multifaceted and relates to health functions such as mineral supplementation, gastrointestinal protective effects and detoxification functions
    MINERAL SUPPLEMENTATION One explanation for geophagy in animals and humans is to help alleviate nutrient deficiencies in susceptible populations. Clay substances contain essential minerals such as calcium, copper, iron, magnesium and zinc and potassium and phosphorus. The majority of the studies examining the mineral supplementation benefits of clays are based on clays consumed in Africa, most notably by women who purchase mineral-rich clays in markets to prevent nutrient deficiency during pregnancy. Consumed regularly, these clays are thought to function similar to a manufactured mineral supplement in industrialized societies. Another example of geophagy is in China where clay is used as a source of minerals to replace body mineral loss that occurs in early starvation. In addition to the repletion of body mineral content, in this case geophagy also assists in the maintenance of fluid and electrolyte balance (homeostasis), thus preventing body fluid losses and reducing the physical stress of fasting on the body.
    DETOXIFICATION AS A FUNCTION OF GEOPHAGY Detoxification is another commonly accepted explanation of geophagy. Ecological research suggests that the practice of geophagy in animals serves to absorb toxins commonly found in their food supply, such as alkaloids, tannins, oxalates, and other toxic plant constituents. Case studies on certain cultural groups, such as the Pomo Indians of California and natives of Sardinia, further support the detoxification function of geophagic behavior. These native societies use clays in the preparation of certain foods with high toxin levels, for example acorn breads. Acorns are very high in tannins, which are toxic, bitter compounds found throughout nature. In both cultures, clays are used as an ingredient in acorn breads to help bind harmful tannins as well as reduce bitterness. Another case study demonstrating the detoxification function of clay is the traditional consumption of clays with certain bitter and toxic types of potatoes in North and South America to bind toxic glycoalkaloid compounds.
    ADSORPTIVE AND ABSORPTIVE PROPERTIES OF CLAYS The gastroprotective and detoxifying effects of clay minerals are directly related to their highly absorptive and adsorptive properties. This sorptive characteristic of clays is believed to be the basis of the majority of the health benefits associated with geophagy. Absorption is the process by which a substance in one state is incorporated into another substance in another state, for example liquid water being absorbed into ice. Adsorption occurs when ions and molecules bind to the surface of another substance via physical or chemical bonds.
    Toxins in the form of minerals (ie. heavy metals), natural organic toxins (such as aflatoxin) or microorganisms such as bacteria, yeast or viruses, are adsorbed and absorbed into the clay mineral matrix as it passes through the digestive tract. By virtue of electrical attraction, positively charged toxins bind to the negatively charged inner and outer surfaces of the clay, and are safely removed from the body along with the clay. A report by the Canadian Journal of Microbiology shows that clay can absorb harmful viruses, aflatoxin, pesticides and herbicides including Paraquat and Roundup. Motmorillonite clay is one of the only types of clays that have both the absorption and adsorption functions. Due to these sorbent properties, clay substances are also effective as gastrointestinal protectors in medicine as they adhere to the gastric and intestinal mucous membrane and protect against invading toxins.
    The absorptive properties of clay also allow them to be useful medicinally both as osmotic oral laxatives and antidiarrheal agents. The antidiarrheal effect of clays is attributed to its sorptive behavior, as absorbent minerals in clays are effective in binding and eliminating excess water and gases from the digestive tract. Smectites and kaolinite are the major antidiarrheal minerals due to their high capacity for water absorption. Sodium smectite minerals in clays act by osmosis, drawing water from the blood plasma through the bowel wall to re-establish osmotic balance to produce a laxative effect. The degree of laxative effect is directly related to the sodium content of the clay, which produces an increase in osmotic pressure in the intestine.
    The sorbtive properties of clays are not limited to the gastrointestinal tract. Clays are also used in dermatological protective preparations due to their ability to absorb skin secretions such as greases, toxins and bacteria thus eliciting a gentle antiseptic action. The effectiveness of clay preparations on inflammatory conditions such as acne, boils and ulcers due to the sorption of negative inflammatory stimuli is well documented in pharmaceutical and cosmetic preparations.
    SIERRASIL® JOINT FORMULA14TM The clinical and anecdotal results with regard to osteoarthritis symptoms experienced by SierraSil® Joint Formula14™ users are mainly attributed to the noted absorptive capacity of clays. Bioaccessibility testing on SierraSil® Joint Formula14™ confirm that only minute quantities of the minerals in SierraSil® Joint Formula14™ are made available by the body for absorption. The remaining minerals pass inertly through the digestive tract in the clay matrix, binding inflammatory toxins during transit and allowing for their safe elimination from the body and elicit a net anti-inflammatory effect. Research is underway to determine further clinical applications for SierraSil® Joint Formula14™ based on historical uses of clays as well as reported anecdotal benefits.
    Is SierraSil® Joint Formula14™ a Significant Source of Dietary Minerals?
    By: Sarah Holvik, B.Sc. Nutritional Science
    SierraSil® is a pure, 100% natural mineral composite containing a wide array of macro and trace minerals in a rich clay structure, used to make SierraSil® Joint Formula14™. The constituent minerals in SierraSil® Joint Formula14™ have been subjected to bioaccessibility testing to determine the quantities available by the body for absorption upon consumption. This testing was performed with the intent of further elucidating the mechanisms of action of the therapeutic effects of SierraSil® Joint Formula14™, as well as to confirm that all levels of constituent minerals fall within regulatory intake limits. The following attempts to clarify the misconceptions regarding the presence of these minerals in SierraSil® Joint Formula14™, and provides contextual information regarding the undesirable mineral constituents and their presence in commonly consumed foods.
    ESSENTIAL MINERALS The essential dietary minerals are divided into two basic categories; macrominerals and microminerals (or trace elements). Macrominerals such as calcium, potassium, sulfur, magnesium, sodium and phosphorus make up approximately 4% of total human body weight, and serve as structural components as well as help regulate osmotic pressure and acid-base balance. The required intake of each of the essential macrominerals is greater than 100 milligrams per day, and can range up to grams per day (ie. calcium), whereas trace elements are required in amounts less than 100 milligrams per day, often much less (ie. microgram amounts). Trace elements are essential components of metabolic constituents such as enzymes, hormones, vitamins and biological catalysts. Deficiency in any one of the essential minerals can lead to serious health consequences, including death. However, some of these minerals are toxic at higher concentrations and have prompted the development of tolerable upper intake levels for minerals.
    SierraSil® Joint Formula14™ contains a wide array of minerals essential to health as well as some which have known toxicity issues. When examining the mineral content of SierraSil® Joint Formula14™, it is important to consider that only minute quantities of each constituent mineral are actually released into the body upon ingestion, as shown by repeated bioaccessibility testing. These quantities of minerals are insignificant in relation to both the required intake levels of the essential minerals in SierraSil® Joint Formula14™, as well as regulatory limits for minerals with toxicity issues. Thus, although it contains a wide spectrum of essential minerals, SierraSil® Joint Formula14™ can not be considered a significant source of dietary minerals as the majority of the minerals in SierraSil® Joint Formula14™ remain in the clay matrix and pass through the body unabsorbed. This analysis also suggests that the mineral content of SierraSil® Joint Formula14™ does not contribute greatly to the overall therapeutic effects, and instead the minerals work synergistically together with the clay component of SierraSil® Joint Formula14™ to elicit the observed therapeutic effects.
    UNDESIRABLE MINERALS Although SierraSil® Joint Formula14™ contains some potentially undesirable minerals, it is important to understand that these minerals exist in similar or higher levels in the environment and common foods. Bioaccessibility testing confirms that the quantities of these minerals in SierraSil® Joint Formula14™ are insignificant and fall far below established toxicity limits. Some examples of potentially harmful minerals contained within SierraSil® Joint Formula14™ include aluminum as well as heavy metal contaminants arsenic, lead, mercury and cadmium. To put some perspective on the amounts of these detrimental minerals in SierraSil® Joint Formula14™, consider the following examples of these minerals in commonly consumed foods.
    Aluminum is a ubiquitous element that is found in abundance in the environment as well as many food products such as grain products, milk, yogurt and cheeses as well as processed foods. An average daily dosage of SierraSil® Joint Formula14™ provides 6 mg aluminum that is available for absorption by the body, which falls far below the regulatory upper tolerable intake limit of 70 mg per day. In contrast, a single slice of individually wrapped processed cheese can contain up to 50 mg aluminum, and a slice of cake or bread made with baking powder may contain 5–15 mg aluminum. The health concerns with aluminum mostly spring from its association with the formation of plaques in patients with Alzheimer’s disease, as well as its health risks in people with impaired kidney function. To date, no causative link between aluminum and Alzheimer’s has been found.
    Dietary arsenic represents the major source of arsenic exposure for the general population. Arsenic exists in many forms with varying reactivity in our environment. Pentavalent and trivalent inorganic arsenic react with biological compounds in the body, and can result in enzyme inactivation, structural damage and disruption of DNA synthesis. In contrast, organic arsenic compounds are considered to be less toxic or nontoxic compared to their inorganic counterparts. Organic arsenic compounds are commonly found in fish at levels between 1 and 10 mg/kg, and in higher levels in seafoods (at or above 100 mg/kg). Despite the seemingly high quantity of arsenic found in these foods, there have been no reports of ill effects among ethnic populations consuming large quantities of organic arsenic containing fish. The bioaccessible arsenic content of an average daily dosage of SierraSil® Joint Formula14™, 0.0007 mg/day, falls far below the amount commonly found in fish and seafood as well as the established upper intake limit of 0.15 mg/day, and thus not be considered a safety concern with SierraSil® Joint Formula14™.
    Crude mineral analysis shows that SierraSil® Joint Formula14™ also contains minute quantities of other potentially undesirable minerals- these include mercury, cadmium and lead. However, as with arsenic, bioaccessibility testing shows that these minerals are also present in much lower quantities in SierraSil® Joint Formula14™ than many commonly consumed foods and thus do not present safety concerns.
    Like arsenic, mercury is also found in fish and shellfish largely in the form of methylmercury, which is recognized as more toxic than inorganic mercury. Mercury targets the nervous system, particularly the developing brain as methylmercury is able to pass through the placenta about 10 times more readily than other mercury compounds. The concentration of methylmercury in most fish is less than 0.4 mg/kg, however predatory species such as swordfish and shark may contain up to several mg/kg. The average daily intake of methylmercury ranges from 0.2 to 3–4 mcg/kg body weight/day, which is dependant on fish and seafood intake. In contrast, bioaccessible mercury in SierraSil® Joint Formula14™ is present in nil amounts in an average daily dosage, well below the upper intake limit of 0.05 mg/day, and thus also does not represent a safety risk.
    Diet and drinking water are the main routes of human exposure to cadmium and lead. The highest concentration of cadmium in foods are found in mollusks, kidney, liver, cereals, cocoa and leafy vegetables. In addition to foods and drinking water, lead-containing manufactured products and air contamination also contribute significantly to lead intake. Infants and children are at the highest risk of lead exposure as they absorb lead from the diet with greater efficiency than adults. As with other potentially undesirable minerals in SierraSil® Joint Formula14™, cadmium and lead levels in SierraSil® Joint Formula14™ do not reach significance as their concentrations are over 100-fold below established upper intake limits.
    MORE THAN ITS MINERAL COMPONENTS From this data, it is apparent that the bioaccessible amounts of both the health-promoting and potentially toxic minerals in SierraSil® Joint Formula14™ are very low based on tolerable upper intake limits and levels commonly found in foods and the environment, and thus do not represent safety concerns. Compounded with the numerous other toxicity studies showing SierraSil® Joint Formula14™ to be non-toxic and safe for human consumption under the recommended conditions of use, the information here serves to provide further support to the safety of SierraSil® Joint Formula14™ as a natural joint health product.
    REFERENCES
    Article 1. Absorptive Minerals – Mechanisms behind Clay’s Medicinal Uses
    1. Aufreiter, S; Hancock, RGV; Mahaney, WC; Stambolic-Robb, A; Sanmugadas, K. Geochemistry and mineralogy of soils eaten by humans. International Journal of Food Science and Nutrition. 1997; 48:293–305
    2. Carretero, MI. Clay minerals and their beneficial effects upon human health: A review. Applied Clay Science. 2002;21:55–163
    3. Johns, T; Duquette, M. Detoxification and mineral supplementation as functions of geophagy. American Journal of Clinical Nutrition; 1991, Vol/Issue: 53:2, 448-56
    4. Phillips TD et al. Reducing human exposure to
    Article 2. Is SierraSil® Joint Formula14™ a Significant Source of Dietary Minerals?
    1. Szefer P, Nriagu J. Mineral Components in Foods. CRC Press, Boca Raton, Florida, 2007
    2. Bioaccessibility tests performed by Cantox Health Sciences International.

    There are hundreds of testimonials the benefits of SierraSil®. These are a select few from knowledgeable experts.

    Dr. Jack Taunton: The results showed that Sierrasil® is safe to use in highly trained athletes and resulted in improvements in anaerobic power and in reducing the level of DOMS post-exercise that the researchers, Dr. Don McKenzie and Dr. Jack Taunton describe as

    “sport significant”.

    TOMMY EUROPE, CELEBRITY PERSONAL TRAINER, FORMAL PROFESSIONAL FOOTBALL PLAYER: I used SierraSil to help with an old shoulder injury from football and continue to take it daily as it’s the best product I’ve found for recovery and eliminating post exercise stiffness.