Hadley, MA - Annatto tocotrienol could help promote bone health in post-menopausal women.

A recent clinical studyconducted at Texas Tech University Health Sciences Center and published inOsteoporosis Internationalprovides a promising new link in vitamin E research.

Results of the 12-week randomized, double-blind, placebo-controlled trial using patented DeltaGold annatto-derived tocotrienol ingredient by American River Nutrition, Inc. indicated significant efficacy on bone biomarkers in osteopenic women. This is the first-ever tocotrienol clinical trial on bone health.

Researchers studied 87 postmenopausal women.  DeltaGold tocotrienol was administered at two dosages, 300 and 600 mg a day, both of which led to decreased bone resorption and improved bone turnover rate (buildup). All subjects, including the placebo group, were also given a daily 400 IU vitamin D and 500 mg calcium supplement.  Researchers found significant improvements in bone biomarkers after 6 weeks, and even more marked at the end of the 12-week study period.

Osteopenia, defined by a thinning of bone mass, is a precursor and serious risk factor for the development of osteoporosis. Anti-osteoporotic drugs are available and aim to slow bone loss, but they can have serious side effects, such as bisphosphonate-related osteonecrosis – or drug-induced decay – of the jaw (BRONJ). As a result, clinical studies are looking into alternative and safer options to protect the aging bone.  According to Dr. Barrie Tan, president of American Nutrition, tocotrienol has been used as a dietary supplement for many years, and no side effects have been reported. He adds, "...tocotrienols from annatto have been tested in a variety of clinical trials, and even at high dosages no adverse effects have been noted." He adds that DeltaGold is also an FDA GRAS-approved ingredient.

The researchers note that the osteoprotective effects of annatto tocotrienol are, in part, mediated through suppression of oxidative stress, which is one of the main culprits associated with symptoms of menopause.  Adds Dr. Tan: “This trial was well-designed and yielded unambiguous findings, where in the post-menopausal state, bone breakdown markers went down, balancing the bone metabolism ratio in a way that promotes healthy bone during a physiologically vulnerable period of life.

“During menopause, women are under excessive oxidative stress, which may contribute to bone breakdown, and, in this research, DeltaGold clearly reverses oxidative DNA damage.”

Since subjects were seeing benefits with tocotrienol above and beyond vitamin D and calcium supplementation, Tan added that he is looking forward to seeing more formulators include tocotrienols in bone health products.