AIDP has announced three-month study results of a double-blind, placebo-controlled U.S.-based clinical trial of KoACT® at Florida State University in Tallahassee, Fla.
KoACT, a patented collagen compound designed for advanced bone strength, was assessed in this study for its efficacy on bone loss. The result has been published in the Journal of Food and Nutritional Disorders, Feb. 1, 2013. Initial study results of the 12-month trial also indicate that KoACT may have the potential to support bone health in osteopenic postmenopausal women.
Led by Dr. Bahram Arjmandi, Margaret A. Sitton professor and chair, department of nutrition, food and exercise sciences and director for the Center for Advancing Exercise and Nutrition Research on Aging, 40 women, one to five years postmenopausal, were randomized to one of two treatment groups to receive daily for three months of either of the following dietary supplements: calcium (control), or KoACT. Bone mineral density of lumbar spine and total body were assessed at baseline and at three months using dual-energy X-ray absorptiometry. Blood was collected at baseline and three months to assess biomarkers of bone metabolism.
KoACT was linked to significantly increased total body bone mineral density when compared to the control group (P<0.05). A significant increase (P<0.05) in the BAP/TRAP5b ratio percent change was indicated for the KoACT group. Bone specific alkaline phosphatase (BAP) is a biochemical marker for bone formation, while TRAP5b are usually associated with bone resorption. Ratio BAP/TRAP5b indicates the balance between bone regeneration versus bone loss. Collectively, these preliminary data suggested that KoACT enhances bone mass potentially by shifting favorably the balance of bone formation versus bone resorption in the process of bone turnover.
“The clinical trial results strongly suggest that KoACT provides additional benefits to strengthen the bone, instead of addressing calcium deficiency only as most of the currently available bone supplements,” said Jennifer Gu, PhD., AIDP director of research and development.
“While further studies are needed to evaluate the mechanisms of action by which KoACT increases bone mass, to achieve such remarkable results in a three-month period of time is quite significant,” added Dr. Gu. The study will continue for 12 months to verify and expand the findings, according to Dr. Gu.
In a previous study at Tokyo University of Science and Technology, KoACT was shown to increase bone mineral density and bone strength in an animal model of osteoporosis. The KoACT results were significantly better than calcium or a simple mixture of calcium and collagen.
The quality of the bone decides the resistance to fracture. Focusing on bone strength, beyond bone density, is critical since 20 percent of hip fracture patients die within one year of incidence. KoACT, a superior solution to bone health above calcium, is self-affirmed GRAS and is registered under three U.S. patents.