RegeneMax® Plus

Scientific Information/Data

Silicon and Choline-Stabilized Orthosilicic Acid

Silicon is a ubiquitous element present in various tissues of the human
body. It performs an important role in connective tissue health, especially in
the formation of the organic matrix (e.g., collagen and glycosaminoglycan
formation).[1] Cereal/grain-based products and vegetables are the main dietary
sources of silicon, but modern processing is likely to reduce intake from
these sources. Soluble silicon is found as orthosilicic acid (OSA) in beverages
and water.[2] Because regular orthosilicic acid is highly unstable, leading it
to form polymers, and because the polymers are too large for the human
body to absorb, RegeneMax Plus features patented “choline stabilization”
technology. This stabilization prevents polymers from forming, ensuring optimal
absorption of orthosilicic acid. Choline-stabilized orthosilicic acid (ch-OSA®) is
a bioavailable form of silicon that has been found to increase the hydroxyproline
concentration in the dermis of animals.[2] Furthermore, the ch-OSA in
RegeneMax Plus is clinically proven for your assurance.*[2-4]

“Beauty Proteins” and Orthosilicic Acid

ch-OSA helps naturally nourish the body’s beauty proteins: collagen, elastin, and
keratin. Collagen is the body’s main structural protein. It makes up 70% of skin
and gives skin its strength and elasticity. It forms 30% of bone to give bones the
flexibility they need to withstand impact. Additionally, the collagen fibers in bone
are the binding sites for calcium and other bone minerals.[5] Collagen is also the
major component of fascia, cartilage, ligaments, and tendons. Unfortunately,
collagen production begins decreasing at age 18. By the age of 40, the decrease
is about 1% per year.[6] For women, the decline equates to a loss of 7% of
skin thickness every 10 years. Following menopause, the decline in thickness
accelerates to as much as 1.13% annually, while skin elasticity degrades 0.55%
per year.[7] Adequate collagen production correlates with healthy bones and
strong hair and nails.*[6-8]

For years, OSA was the focus of intense research because it was viewed as a
potential collagen generator. As a result of that research, the molecular complex
known ch-OSA was created. Choline not only has the positively charged
nitrogen atom that forms the vital bond with OSA, but according to leading
collagen researchers, choline transports the orthosilicic acid into target cells
where it activates the pathways involved in collagen production. Clinical trials
also suggest that beyond its ability to generate collagen, ch-OSA promotes
keratin and elastin formation—two proteins that assist in skin elasticity and hair
tensile strength.*[2-4

ch-OSA Clinical Studies

In a 20-week, randomized, double-blind, placebo-controlled study of 50 women
with photo-damaged facial skin, oral intake of 10 mg/d silicon as ch-OSA
resulted in significantly improved skin visco-elastic properties and a 19%
reduction in roughness with a 30% reduction in micro-wrinkle depth (measured
as maximum roughness) compared to placebo.[2] In the same clinical trial,
the women’s hair and nails showed significant improvements in strength.
Furthermore, serum silicon was significantly higher (+72%) in subjects after 20
weeks of supplementation with ch-OSA compared to the placebo group. In a
nine-month, randomized, double-blind, placebo-controlled trial with 48 healthy
Caucasian women with fine hair (average age 43.3 years), 10 mg/d of silicon as
ch-OSA for nine months improved hair tensile strength including elasticity and
break load and resulted in thicker hair.*[3]

In a 12-month clinical trial conducted at St. Thomas’ Hospital in London,
women already taking 1000 mg of calcium and 800 IU of vitamin D, to which
they added ch-OSA, saw thighbone mineral density at the hip (i.e., femoral
neck) increase by 2.00% compared to placebo. This was as a result of an
increase in actual bone formation, not just a decrease in loss.[4] Furthermore,
the procollagen marker P1NP (procollagen type-1 N-terminal propeptide)
increased significantly after 12 months in women who took ch-OSA compared
to women in the placebo group. P1NP is known as the most sensitive marker
for bone collagen formation and an early marker of bone formation.[4] Animal
studies support the human clinical findings for ch-OSA with respect to collagen
formation and bone mineral density.*[9-11]

In an open clinical study, 18 subjects were given five drops of ch-OSA twice
daily for six months. Hair growth and hair loss assessments were performed
using a semi-quantitative rating scale, and scores were analyzed using the
Friedman test. At the end of the six months, 94% of respondents had improved
hair growth with 58% in the categories of moderate to marked hair growth. All
respondents noted improvement in the body and texture of their hair.*[12]

Biotin

Biotin, as an essential component of carboxylase enzymes, has diverse roles
in maintaining health. While overt biotin deficiency is known to result in skin
irritation and hair loss, anecdotal evidence suggests that biotin supplementation
supports healthy hair growth, and supplementing with biotin is a common
method for enhancing skin health and hair and nail strength. Studies testing the
effects of biotin on nail health suggest that biotin supplementation improves
nail thickness and reduces splitting.[13-15] In one study, 91% of subjects showed
definite improvement with firmer and harder finger nails after 5.5+/-2.3 months
of 2.5 mg/d biotin.[16] Higher doses of biotin (9 mg to 16 mg/d) are used to
support healthy lipid and glucose metabolism; and more recently, doses up
to 300 mg/d have been used to support muscle function related to neurologic
health.*[17,18]

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

References

1. Carlisle EM. Silicon as a trace nutrient. Sci Total Environ. 1988 Jul1;73(1-2):95-
106. [PMID: 3212453]
2. Barel A, Calomme M, Timchenko A, et al. Effect of oral intake of cholinestabilized orthosilicic acid on skin, nails and hair in women with photodamaged
skin. Arch Dermatol Res. 2005 Oct;297(4):147-153. [PMID: 16205932]
3. Wickett RR, Kossmann E, Barel A, et al. Effect of oral intake of choline-stabilized
orthosilicic acid on hair tensile strength and morphology in women with fine
hair. Arch Dermatol Res. 2007 Dec;299(10):499-505. [PMID: 17960402]
4. Spector TD, Calomme MR, Anderson SH, et al. Choline-stabilized orthosilicic
acid supplementation as an adjunct to calcium/vitamin D3 stimulates markers
of bone formation in osteopenic females: a randomized, placebo-controlled trial.
BMC Musculoskelet Disord. 2008 Jun 11;9:85. [PMID: 18547426]
5. Viguet-Carrin S, Garnero P, Delmas PD. The role of collagen in bone strength.
Osteoporos Int. 2006;17:319-336. [PMID: 16341622]
6. Shuster S. Osteoporosis, a unitary hypothesis of collagen loss in skin and bone.
Med Hypotheses. 2005;65(3):426-432. [PMID: 15951132]
7. Calleja-Agius J, Muscat-Baron Y, Brincat MP. Skin ageing. Menopause Int. 2007
June;13(2):60-4. [PMID: 17540135]
8. Sumino H, Ichikawa S, Abe M, et al. (2004). Effects of aging and
postmenopausal hypoestrogenism on skin elasticity and bone mineral density in
Japanese women. Endocr J. 2004 Apr;51(2):159-164. [PMID: 15118265]
9. Calomme MR, Vanden Berghe DA. Supplementation of calves with stabilized
orthosilicic acid. Effect on the Si, Ca, Mg, and P concentrations in serum and
the collagen concentration in skin and cartilage. Biol Trace Elem Res. 1997
Feb;56(2):153-165. [PMID: 9164661]
10. Calomme MR, Wijnen P, Sindambiwe JB, et al. Effect of choline-stabilized
orthosilicic acid on bone density in chicks. Calcif Tissue Int. 2002, 70:292.
Poster presented at: 29th European Symposium on Calcified Tissues; May
25-29, 2002; Zagreb, Croatia. http://www.ectsoc.org/zagreb2002/poster3.htm.
Abstract P-139. Accessed December 16, 2015.
11. Calomme MR, Geusens P, Demeester N, et al. Partial prevention of long-term
femoral bone loss in aged ovariectomized rats supplemented with cholinestabilized orthosilicic acid. Calcif Tissue Int. 2006, Apr;78(4): 227-232. [PMID:
16604283]
12. Chan G. An open clinical study of the efficacy of choline-stabilized orthosilicic
acid in the management of hair loss. A pilot study. Paper presented at: 17th
Regional Conference of Dermatology; September 13-16, 2006; Bali, Indonesia.
13. Colombo VE, Gerber F, Bronhofer M, et al. Treatment of brittle fingernails and
onychoschizia with biotin: scanning electron microscopy. J Am Acad Dermatol.
1990 Dec;23(6 Pt 1):1127-32. [PMID: 2273113]
14. Hochman LG, Scher RK, Meyerson MS. Brittle nails: response to daily biotin
supplementation. Cutis. 1993 Apr;51(4):303-5. [PMID: 8477615]
15. Scheinfeld N, Dahdah MJ, Scher R. Vitamins and minerals: their role in nail
health and disease. J Drugs Dermatol. 2007 Aug;6(8):782-7. Review. [PMID:
17763607]
16. Floersheim GL. Treatment of brittle fingernails with biotin [in German]. Z Hautkr.
1989 Jan 15;64(1):41-8. [PMID: 2648686]
17. Sedel F, Bernard D, Mock DM, et al. Targeting demyelination and virtual
hypoxia with high-dose biotin as a treatment for progressive multiple sclerosis.
Neuropharmacology. 2015 Sep 5. [Epub ahead of print] [PMID: 26327679]
18. Biotin: Monograph. Alt Med Rev. 2007;12(1):73-78. [on file]