Clinical Study Identifies Bone Health Benefits of DeltaGold® Tocotrienols

Annatto tocotrienol is a promising bone health promoter, suggests published clinical study in post-menopausal women.

A recent study conducted at Texas Tech University Health Sciences Center, published in the high-impact peer-reviewed journal, Osteoporosis International (January 12, 2018), provides a promising new link in the chain of vitamin E research. Results of the 12-week randomized, double-blind, placebo-controlled trial of the 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.

In the 12-week study of 87 postmenopausal women, DeltaGold tocotrienol was administered at two dosages (300 and 600mg/day), both of which led to decreased bone resorption and improved bone turnover rate (buildup). This was compared to an independent and blinded control group that was given a placebo. All subjects, including the placebo group, were also given a daily 400IU vitamin D and 500mg calcium supplement. The protocol for this study was in full disclosure and previously published: Shen C-L, Mo H, Yang S, et al. Safety and efficacy of tocotrienol supplementation for bone health in postmenopausal women: protocol for a dose–response double-blinded placebo-controlled randomized trial. (BMJ Open 2016;6:e012572. doi:10.1136/bmjopen-2016- 012572.)

Study Details

Osteopenia, defined by a thinning of bone mass, is a precursor and serious risk factor for the development of osteoporosis. According to the International Osteoporosis Foundation, osteoporosis is estimated to affect 200 million worldwide, and causes about 9 million fractures annually. Further, the National Osteoporosis Foundation reports that 22 million American women and 12 million men have osteopenia. 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). Hence, clinical studies are looking into alternative and safer options to protect the aging bone.

Bone biomarkers that were examined included bone-specific alkaline phosphatase (BALP; bone formation), N-terminal telopeptide (NTX; bone resorption), soluble receptor activator of nuclear factor-kappaB ligand (sRANKL; bone resorption), and osteoprotegerin (OPG; bone formation).

Significant improvements in bone biomarkers were evident after 6 weeks, and even more marked at the end of the 12-week study period. For example, the BALP/NTX ratio (a higher ratio is a measure for bone remodeling) increased ~40% at 6 weeks, and was much higher at 12 weeks, with increases of ~100% for both groups. These results indicate that bone metabolism was strongly favored by supplementation, particularly for the 300mg/d group.

RANKL is a ligand secreted by osteoblasts, which binds to receptors on osteoclasts and stimulates bone resorption. OPG, on the other hand, inhibits osteoclasts and triggers bone formation. A higher ratio of RANKL/OPG signifies bone resorption. In this trial, the ratio decreased 7-13% after only 6 weeks, and further decreased 13-24% after 12 weeks of tocotrienol supplementation, whereas the ratio of the placebo group increased by 21-36%.

The researchers note that the osteoprotective effects of annatto tocotrienol are, in part, mediated through suppression of oxidative stress, which manifested through a remarkable 49% decrease in urine 8-hydroxy-2’-deoxyguanosine (8-OHdG), a stable and reliable oxidative stress biomarker of DNA breakdown product.

Commenting on the research, Dr. Barrie Tan, President of American River Nutrition Inc. said that “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,” he explains. 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.

Supplement Details

Vitamin E is a family of eight separate but related molecules: four tocopherols (alpha, beta, gamma, delta) and four tocotrienols (alpha, beta, gamma, delta). While alpha-tocopherol is found in most multivitamins and is supplemented in foods, a growing base of evidence suggests that this popular vitamin E interferes with the uptake and function of tocotrienols. Tocotrienols are derived from three major sources, including rice, palm and annatto.

Source: Osteoporosis International doi: 10.1007/s00198-017-4356-x Tocotrienols supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial.

Authors: Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H

About American River Nutrition

American River Nutrition, founded in 1998, is the producer of DeltaGold^® tocotrienols, the most beneficial form of vitamin E for cardiovascular health, as well as other health benefits. The company is led by Dr. Barrie Tan, a pioneering scientist and researcher credited with identifying the primary sources of plant-based tocotrienols, including rice, palm & the virtually 100% tocotrienol-producing annatto plant. American River products are manufactured in the U.S. using a proprietary process leading to the purest form of natural tocotrienols available.