Natural Mineral Concentrate Solution (NMCS) Clinical Trial

Supplementing with natural minerals protects cartilage and improves moderate knee osteoarthritis.

Abstract

Objective: 

The primary aim of this trial was to determine whether Natural Mineral Concentrate Solution (NMCS) acts as a cartilage-protective agent by assessing the WOMAC score, 6-minute walk distance (6MWD) without pain, and the need for rescue analgesics.

Methodology: 

A double-blind, placebo-controlled, randomized trial was conducted in 100 patients with moderate knee osteoarthritis. The treatment group received 40 drops of NMCS once daily. Efficacy was objectively confirmed by evaluating changes in cartilage thickness, joint space width (JSW), and synovial fluid composition.

Results: 

Over 24 weeks, the NMCS group showed significant improvements in WOMAC scores and 6MWD compared with the placebo group. Ultrasound and synovial fluid analysis revealed improvements in cartilage structure. Patients tolerated the treatment well, and there were no significant differences in adverse event profiles between groups.

Introduction

Minerals are essential for many bodily functions, and even slight imbalances in intracellular mineral composition can cause serious physiological effects. Trace elements such as zinc, copper, selenium, magnesium, manganese, and nutrients like vitamins A, C, E, niacin, pantothenic acid, omega-3 fatty acids, chondroitin, glucosamine, collagen, hyaluronic acid, and boron-containing amino acids play important roles in the production of sulfated cartilage matrix.

Natural minerals such as magnesium, copper, manganese, selenium, and zinc have shown anti-inflammatory effects in both animal and human studies. In rat osteoarthritis models, dietary magnesium deficiency increased cartilage damage, whereas increased dietary magnesium could reduce inflammation by lowering serum levels of C-reactive protein.

Copper, a trace element, is an essential cofactor for enzymes like lysyl oxidase, which crosslinks collagen. Excess reactive oxygen species (ROS) resulting from an imbalance in joint antioxidant status can lead to cartilage degradation and joint deformities. Antioxidant enzymes such as superoxide dismutase require copper, zinc, and manganese as cofactors. Mineral supplementation in human cartilage explant models reduced IL-1β-induced cartilage degradation and secondary nitric oxide production. Selenium, a cofactor for glutathione peroxidase, may also reduce the incidence of osteoarthritic lesions.

Boron, manganese, and selenium have been reported to slow disease progression and reduce symptom severity in osteoarthritis. Studies on seaweed-derived multi-mineral supplements (Aquamin), Sierra Nevada mineral products (Sierrasil), and Phytalgic showed partial improvement in WOMAC scores for pain, function, stiffness, as well as 6MWD and reduced NSAID use after 12 weeks.

Studies on glucosamine and chondroitin alone have shown variable results, suggesting potential limitations in these approaches, possibly due to inadequate cofactor intake, particularly minerals and trace elements.

Based on prior studies showing beneficial effects of minerals in patients with joint pain, this study evaluated the subjective and objective effects of NMCS in moderate knee osteoarthritis without claiming therapeutic efficacy.

Materials and Methods

The dietary supplement used in this clinical trial was NMCS, a concentrated trace mineral solution derived from the Great Salt Lake in Utah, containing over 72 ionic minerals. It is 100% natural with no additional ingredients (see Table 1 for typical mineral composition).

Table 1. Mineral composition of NMCS

Inclusion criteria: Patients aged ≥50 years with symptomatic primary knee osteoarthritis, experiencing daily pain for the past 3 months regardless of weekly analgesic use or WOMAC score, and morning stiffness <30 minutes. Target knee WOMAC score ≤75.

Table 2. Kellgren's Grade Scale

Table 3. Brandt's radiographic grading scale for tibiofemoral osteoarthritis

Table 4. Ahlback's radiographic grading scale for

osteoarthritis of the tibiofemoral joint.

Radiographic criteria: Kellgren-Lawrence grade 0–3 (Table 2), Brandt radiographic OA grade 1–2 (Table 3), and Ahlbäck tibiofemoral OA grade 0–1 (Table 4). If both knees were symptomatic, only the more painful knee was considered.

Exclusion criteria: Secondary knee OA, severe OA (JSW <2 mm), intra-articular injections or corticosteroids within 3 months, prior diacerein treatment within 3 months, or clinically significant systemic disease.

100 subjects were randomized in a double-blind manner to receive NMCS or placebo for 24 weeks. Participants were advised to take NMCS twice daily on an empty stomach, starting at 5–10 drops and increasing weekly to 40 drops (½ tsp).

Baseline evaluations included vital signs, WOMAC scores, 6MWD, joint space width, cartilage thickness, and synovial fluid cellularity. Weekly assessments were conducted for the first month, followed by monthly follow-ups for 6 months. X-ray, ultrasound, synovial fluid, and other tests were repeated at 6 months.

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) assessed pain, stiffness, and physical function using 5, 2, and 17 questions respectively, with total scores ranging from 0–96. Pain severity was also measured using the Andrea Mankoski scale (Table 5).

6MWD was performed in a 50-meter indoor corridor. JSW was measured from anterior-posterior knee radiographs under weight-bearing conditions. Ultrasound assessed cartilage thickness. Safety evaluations included adverse events and laboratory tests. Adverse events were classified by severity and causality. Ethical approval was obtained, and all patients provided informed consent.

Table 5. Andrea Mankoski's pain scale

Results

Baseline characteristics were comparable across all groups (Table 6). Four NMCS patients and three placebo patients did not complete the study due to personal reasons or study invalidation. One NMCS patient experienced nausea that resolved after discontinuation.

Both groups showed improvements from baseline in WOMAC scores over 24 weeks (Table 7), with NMCS improvements significantly greater (p <0.005). At weeks 4, 8, and 12, NMCS showed noticeable improvements versus baseline, though not significant versus placebo (p>0.05).

NMCS significantly improved composite WOMAC scores at weeks 12 and 24 (7.1 and 16.2 points) versus placebo (4.3 and 7.1 points). At week 12, 34% of NMCS patients reported ≥5-point improvement versus 8% in placebo; at week 24, 52% versus 21%. Pain, stiffness, and function scores improved more in NMCS patients at both time points.

6MWD improved significantly in the NMCS group over time (80 ft, 122 ft) versus placebo (30 ft, 46 ft), with a greater proportion achieving ≥100 ft improvement. Rescue medication use (paracetamol) decreased 23% in the NMCS group.

Radiographs showed no significant JSW changes. Ultrasound showed cartilage thickness increases in 13% of NMCS patients versus 4% in placebo, while thickness loss occurred in fewer NMCS patients. Synovial fluid analysis suggested NMCS aided recovery of fluidity and cartilage metabolism.

Adverse events were similar across groups, mostly mild upper GI discomfort that resolved within 8 weeks. Blood and biochemical safety parameters indicated NMCS was safe. Vital signs remained stable throughout the study.

Discussion

Given the cardiovascular, gastrointestinal, and renal risks associated with NSAIDs and their symptom-only effects, alternative treatments are needed. NMCS is a natural, readily available supplement, already used by consumers. Balanced ionic minerals maximize efficacy, and chelated forms improve bioavailability.

Dosages were based on daily mineral allowances. Severe OA patients were excluded due to limited cartilage recovery potential. NMCS showed early, significant benefits versus placebo, with 6MWD improvement of 9.6% versus 3.5% in placebo over 24 weeks. Early improvements align with in vitro studies showing IL-1β-mediated cartilage protection.

While MRI is more comprehensive, ultrasound is simpler and cost-effective for early cartilage changes. Conventional radiographs detect structural changes later. Limitations include short duration (24 weeks), small sample size, and lack of post-treatment follow-up. Longer studies are warranted.

Table 8

Conclusion

Natural mineral supplements, alone or combined with other nutrients, can improve joint health and significantly alleviate osteoarthritis symptoms within 4 weeks, with excellent safety.

References

1. ACR Guidelines for the Medical Management of Osteoarthritis of the Knee, 2000 Update

2. Bellamy N, Buchanan WW et al. Validation Study of the WOMAC: A Health Status Instrument for Measuring Clinically Important Patient-Related Outcomes in Response to Antirheumatic Drug Treatment in Patients with Osteoarthritis of the Hip or Knee. J Rheumatol. 1988;15:1833-1840

3. Chaojeannie: Ultrasound Assessment of Knee Osteoarthritis: Recent Advances and Future Prospects. Current Opinion in Rheumatology 2008,20(5)

4. Connor JR, Manning PT, Settle SL, Moore WM, Jerome GM, Webber RK, Tjoeng FS, Currie MG. Suppression of Adjuvant-Induced Arthritis by Selective Inhibition of Inducible Nitric Oxide Synthase. Eur J Pharmacol. 1995;273:15-24 doi:10.1016/0014-2999(94)00672-T

5. Frestedt JL, Kuskowski MA, Zenk JL: A natural seaweed-derived mineral supplement (Aquamin F) for knee osteoarthritis: a randomized, placebo-controlled pilot trial. Nutr J. 2009 Feb 2;8:7

6. Gaby AR. Natural treatments for osteoarthritis. Altern Med Rev 1999;4:330-341

7. Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G, Shoor S, Ray WA. Risk of acute myocardial infarction and acute cardiac death in patients treated with cyclooxygenase-2-selective and nonselective nonsteroidal anti-inflammatory drugs: a nested case-control study. Lancet 2005;365:475-81

8. Harrison's Principles of Internal Medicine, 14th Edition, Vol. 1 and 2, pp. 489-492 / 446-447 / 1931

9. Helotin Y, Kurz B, Aigner T. Oxygen and Reactive Oxygen Species in Cartilage Degradation: Friend or Foe? Osteoarthritis and Cartilage / OARS, Osteoarthritis Research Society. 2005;13:643-654 doi:10.1016/j.joca.2005.04.002

10. Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic vs. Placebo in Patients with Knee or Hip Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Arthritis Res Ther 2009;11(6):R192. Epub 2009 December 16

11. Joy L. Freestead, Melanie Walsh, Michael A. Kuskowski, John L. Zenk. Natural mineral supplements alleviate symptoms of knee osteoarthritis: a randomized controlled pilot trial. Nutr J. 2008;7:9

12. King DE, Main AG, 3, Gacy-Woolson RF. Dietary magnesium and C-reactive protein levels. Journal of the American Academy of Nutrition. 2005;24:166-171. Kurz B, Jost B, Schunke M. Dietary vitamins and selenium reduce the development of mechanically induced osteoarthritis and increase antioxidant enzyme expression in the knee joints of STR/1N mice. Osteoarthritis and Cartilage/OARS, Osteoarthritis Research Society 2002;10:119-126. See doi:10.1053/joca.2001.0489. Lequesne M. Indicators of osteoarthritis severity and disease activity. Seminars in Arthritis and Rheumatism 1991;20(Suppl 2):48-54

13. Lequesne M, Brandt K, Bellamy N, Moskowitz R, Menkes C J, Pelletier J P, et al. Guidelines for testing slow-acting drugs in osteoarthritis. J Rheumatol Suppl 1994;41:65-71;discussion 72-3;erratum,2395

14. McAlindon T. Why are glucosamine clinical trials not uniformly positive? Rheum Dis Clin North Am. 2003;29:789-801 doi:10.1016/S0889-857X(03)00064-4

15. McAlindon TE, Biggee BA. Nutritional components and osteoarthritis: Recent developments. Curr Opin Rheumatol. 2005;17:647-652 doi:10.1097/01.bor.0000175461.57749.46

16. Miller MJS, Ahmed S, Bobrowski P, Haqqi TM. Inhibition of chondrocyte degradation and chondrocyte activation by a unique mineral supplement (sierrasil™) and cat's claw extract, vincaria®. J Amer Nutr Assoc. 2004;7:32-39

17. [Claim 2] The therapeutic agent for osteoarthritis described in claim 1. [Claim 4] The therapeutic agent for osteoarthritis according to claim 1, wherein the therapeutic agent is selected from the group consisting of (a), (b), and (c) a randomized controlled trial [ISRCTN38432711] Journal of inflammation (London, England) 2005, 2:11

18. Ravaud P, Auleley GR, Chastang C, Rousselin B, Paolozzi L, Amor B, et al. Knee joint tarsometry: An experimental study on the effects of radiography and joint position. Br J Rheumatol 1996; 35:761-6

19. Sasaki S, Iwata H, Ishiguro N, Habuchi O, Miura T. Low-selenium diet, bone, and articular cartilage in rats. Nutrition (Burbank, Los Angeles County, California 1994; 10:538-543)

20. 2000 Update of the ACR Guidelines for the Medical Management of Osteoarthritis of the Knee

21. Bellamy N, Buchanan WW et al. Validation Study of the WOMAC: A Health Status Instrument for Measuring Clinically Important Patient-Related Outcomes in Response to Antirheumatic Drug Treatment in Patients with Osteoarthritis of the Hip or Knee. J Rheumatol. 1988; 15:1833-1840

22. Chaojeannie: Ultrasound Assessment of Knee Osteoarthritis: Recent Advances and Future Prospects. Current Opinion in Rheumatology 2008, 20(5)

23. Connor JR, Manning PT, Settle SL, Moore WM, Jerome GM, Webber RK, Tjoeng FS, Currie MG. Suppression of Adjuvant-Induced Arthritis by Selective Inhibition of Inducible Nitric Oxide Synthase. Eur J Pharmacol. 1995;273:15-24 doi:10.1016/0014-2999(94)00672-T

24. Frestedt JL, Kuskowski MA, Zenk JL: A natural seaweed-derived mineral supplement (Aquamin F) for knee osteoarthritis: a randomized, placebo-controlled pilot trial. Nutr J. 2009 Feb 2;8:7

25. Gaby AR. Natural treatments for osteoarthritis. Altern Med Rev 1999;4:330-341

26. Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G, Shoor S, Ray WA. Risk of acute myocardial infarction and acute cardiac death in patients treated with cyclooxygenase-2-selective and nonselective nonsteroidal anti-inflammatory drugs: a nested case-control study. Lancet 2005; 365: 475-81

27. Harrison's Principles of Internal Medicine, 14th Edition, Vol. 1 and 2, pp. 489-492 / pp. 446-447 / pp. 1931

28. Helotin Y, Kurz B, Aigner T. Oxygen and Reactive Oxygen Species in Cartilage Degradation: Friend or Foe? Osteoarthritis and Cartilage / OARS, Osteoarthritis Research Society. 2005; 13: 643-654 doi: 10.1016/j.joca.2005.04.002

29. Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic vs. Placebo in Patients with Osteoarthritis of the Knee or Hip: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Arthritis Res Ther 2009; 11(6): R192. Epub 2009 December 16th

30. Joy L. Freestead, Melanie Walsh, Michael A. Kuskowski, John L. Zenk. Natural mineral supplements alleviate symptoms of knee osteoarthritis: a randomized controlled pilot trial. Nutr J. 2008;7:9

31. King DE, Main AG, 3, Gacy-Woolson RF. Dietary magnesium and C-reactive protein levels. Journal of the American Academy of Nutrition. 2005;24:166-171. Kurz B, Jost B, Schunke M. Dietary vitamins and selenium reduce the development of mechanically induced osteoarthritis and increase antioxidant enzyme expression in the knee joints of STR/1N mice. Osteoarthritis and Cartilage/OARS, Osteoarthritis Research Association 2002;10:119-126. See doi:10.1053/joca.2001.0489. Lequesne M. Indicators of osteoarthritis severity and disease activity. Seminars in Arthritis and Rheumatism 1991;20(Suppl 2):48-54

32. Lequesne M, Brandt K, Bellamy N, Moskowitz R, Menkes C J, Pelletier J P, et al. Guidelines for testing slow-acting drugs in osteoarthritis. J Rheumatol Suppl 1994;41:65-71;discussion 72-3;erratum,2395

33. McAlindon T. Why are clinical trials of glucosamine not uniformly positive? Rheum Dis Clin North Am. 2003;29:789-801 doi:10.1016/S0889-857X(03)00064-4

34. McAlindon TE, Biggee BA. Nutritional Components and Osteoarthritis: Recent Trends. Curr Opin Rheumatol. 2005;17:647-652 doi:10.1097/01.bor.0000175461.57749.46

35. Miller MJS, Ahmed S, Bobrowski P, Haqqi TM. Inhibition of Chondrocyte Degradation and Chondrocyte Activation by a Unique Mineral Supplement (Sierrasil™) and Cat's Claw Extract, Vincaria®. J Amer Nutr Assoc. 2004;7:32-39

36. [Claim 2] The therapeutic agent for osteoarthritis described in claim 1. [Claim 4] The therapeutic agent for osteoarthritis described in claim 1, comprising the following (a), (b), and (c) randomized controlled trials [ISRCTN38432711] Journal of Inflammation (London, England) 2005, 2:11

37. Ravaud P, Auleley GR, Chastang C, Rousselin B, Paolozzi L, Amor B, et al. Knee joint tarsometry: An experimental study on the effects of radiography and joint position. Br J Rheumatol 1996;35:761-6

38. Sasaki S, Iwata H, Ishiguro N, Habuchi O, Miura T. Low-selenium diet in rats, bone and articular cartilage. Nutrition (Burbank, Los Angeles County, CA 1994;10:538-543)

39. Shakibaei M, Kociok K, Forster C, Vormann J, Gunther T, Stahlma

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