May 15, 2006

STATE COLLEGE, PA—An ongoing clinical study designed to show the effects of a unique new product, CH-Alpha™, is being conducted at Penn State University. CH-Alpha™ is made from natural collagen, an essential building block of the body’s joints.

Study Design

The study has enrolled 150 student-athletes aged 17 to 25 years who participate in varsity and non-varsity sports and experience joint stiffness or discomfort from stress, injury, surgery, or other joint trauma. The students, males and females in approximately equal numbers, were randomly assigned to receive either an inactive placebo or a dietary supplement containing 10 grams of collagen hydrolysate, a collection of the essential amino acid components of collagen, the building blocks of cartilage.

The Penn State athletes are taking either a collagen hydrolysate supplement or placebo once daily, in a liquid preparation of identical appearance and taste, and will complete a questionnaire every six weeks throughout the six-month study. The questionnaire was designed to identify the joints affected, other factors relating to joint pain or discomfort, and functional improvements or other changes in the affected joints throughout the duration of the study.

Leading the study are Kristine Clark, Ph.D., R.D., assistant professor of nutrition at Penn State University and director of sports nutrition for the Penn State athletic department, and Wayne Sebastianelli, M.D., professor of orthopedic surgery at the Milton S. Hershey Medical Center in Harrisburg, Pa., and head team physician for the department of athletics at Penn State.

Prevalence of Chronic Joint Symptoms in the U.S.

Chronic joint symptoms are America’s leading cause of disability in people aged 18 and older, ultimately affecting about 70 million people.^11,12 This number is likely to climb significantly in the future, as the population over age 50 is expected to double by 2020.¹²

Collagen Hydrolysate and Joint Health

Clinical, laboratory, and animal studies conducted over the past 25 years strongly suggest that collagen hydrolysate can regenerate cartilage, ease joint stiffness and discomfort, and increase joint function. A key laboratory study found that collagen hydrolysate, when added to cultures of chondrocytes (the cells that produce and regulate the production of cartilage in joints), increased the production of type II collagen. Type II collagen makes up 90 percent of the cartilage in hyaline cartilage, suggesting that collagen hydrolysate can help strengthen joints.¹

A study of collagen hydrolysate using C-14 labeled product in laboratory animals found that it was actively absorbed through the gastrointestinal tract and preferentially accumulated in joints, suggesting that the unique amino acid and peptide profile of collagen hydrolysate may be responsible for previous reports of clinical success of CH-Alpha™ in chronic joint symptoms.^6,7

In human studies, a daily oral dose of 10 grams of collagen hydrolysate decreased student-athletes' use of analgesic drugs by as much as 81 percent.³ Numerous other human studies lasting from 14 to 24 weeks found that collagen hydrolysate in the same dose significantly reduced pain and joint discomfort, increased mobility and strength in afflicted joints, and reduced the use of nonsteroidal anti-inflammatory drugs such as aspirin and ibuprofen.^3-10 All of the studies used the collagen hydrolysate formula found in CH-Alpha™.

CH-Alpha™

CH-Alpha™ is a pleasant-tasting liquid in a vial that provides 10 grams of Bioactive Collagen Peptides™, a unique collection of proteins and amino acids, which are the building blocks necessary for joint health. Unlike other supplements, CH-Alpha™ is a natural product with an amino acid composition that is identical to the collagen found in the extracellular matrix in joints. It is the only product proven to stimulate chondrocytes, which are responsible for the maintenance of the extracellular matrix. Studies have shown that CH-Alpha™ increases the concentration of type II collagen and proteoglycans through the stimulation of chondrocytes.

Developed by GELITA Health Products, which is the only company to support scientific research with collagen hydrolysate since the late 1970s, CH-Alpha™ was created specifically for people with joint stiffness, reduced joint flexibility from cartilage breakdown, and other chronic joint symptoms.

The unique Bioactive Collagen Peptides™ in CH-Alpha™ are readily absorbed into the blood after oral ingestion, and have been proven to promote joint health, with increased motion and flexibility, when taken daily for 2 to 3 months. CH-Alpha™ is free of preservatives, additives, cholesterol, and saturated fatty acids, and is made in compliance with the Good Manufacturing Practices set forth in The Dietary Supplement Health and Education Act (DSHEA). The U.S. Food and Drug Administration has approved CH-Alpha™ as being Generally Recognized as Safe (GRAS) as an ingredient in food, affirming its safety for long-term use.

References

1. Oesser, S, Seifert J. Stimulation of type II collagen biosynthesis and secretion in bovine chondrocytes cultured with degraded collagen. Cell Tissue Res. 311:393-399, 2003.
2. Oesser, S, Adam M, Babel W, Seifert J. Oral administration of 14-C-labeled gelatin hydrolysate leads to an accumulation of radioactivity in cartilage of mice. (C57/BL) Am. J. Nutr. 129:1891-1895, 1999.
3. Bueker F, Eck T, Rosenfeld J. Biomedical and clinical examinations on the effects of gelatine on degenerative damage of the moteric system. Int'l J Sports Med. 1996; 12-17.
4. Moskowitz, RW. Role of collagen hydrolysate in bone and joint disease. Seminars in Arthritis and Rheumatism. 30(2):87-99, (October) 2000.
5. Seeligmueller K, Happel, HK. Can a mixture of gelatine and L-cystine stimulate proteoglycan synthesis? Therapiewoche. 39:3153-3157, 1989.
6. Seeligmueller K, Happel, HK. Help and support for cartilage. Therapiewoche. 43:1810-1813, 1993.
7. Adam M. Welche Wirkung haben Gelatinepraparate? Therapiewoche 41:2456-2461, 1991.
8. Oberschelp U. Indiviuelle Arthrosetherapie is moglich. Therapiewoche 44:5094-5097, 1985.
9. Goetz B. Gut genaehrter Knorpel knirscht nicht mehr. Aertizliche Praxis 92:3130-3134, 1982.
10. Krug E. Zur unterstutzenden Therapie bei Osteo- und Chondropathien. Zeitschrift fur Ehrfahrungsheilkunde 11:930-938, 1979.
11. Bolen J, Helmick CG, Sacks JJ, Langmaid G. Prevalence of self-reported arthritis or chronic joint symptoms among adults—United States, 2001. Morb and Mortal Wkly Rep. 2002;51:948-950.
12. United States Bone and Joint Decade. Facts & figures: Fast facts on the bone and joint decade. Available at: http://www.usbjd.org/about/index.cfm?pg=fast.cfm. Accessed March 27, 2006.

For more information, please contact:

Marla Bianchini
Phone: 712-943-0393
marla.bianchini@gelita.com

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