The study design aims to assess the safety and efficacy of tocotrienols for lipid-related parameters in obese postmenopausal women.
According to a paper published in BMJ Open, annatto tocotrienol’s potential anti-obesity effects are to be evaluated in post-menopausal women. The study design aims to assess the safety and efficacy of tocotrienols for lipid-related parameters in obese postmenopausal women. The six-month randomized, double-blind, placebo-controlled trial will be conducted at Texas Tech University Health Sciences Center and will utilize DeltaGold® annatto-derived tocotrienol by American River Nutrition (Hadley, MA). This will be the first-ever tocotrienol clinical trial on an obese population.
In the six-month study, approximately 60 postmenopausal women will be recruited and randomized to receive either a placebo or 300 mg/d of DeltaGold tocotrienol. The primary outcome measure will include determination of total/regional fat mass and visceral adipose tissue, with secondary outcomes measuring changes in the lipid profile, metabolism-related gene expression, fatty acid metabolites, and the gut microbiome.
“[I am] pleased to see this first-ever tocotrienol clinical trial on an obese population commence,” said Barrie Tan, PhD, president of American River Nutrition, in a press release. “This study attempts to quantify the role of tocotrienol in human adiposity in novel ways, measuring not only the mount of adipose tissue, but also adipose tissue bioavailability, adipose inflammation, and weight loss.”
Aryaie A. et al. “Actions of annatto-extracted tocotrienol supplementation on obese postmenopausal women: study protocol for a double-blinded, placebo-controlled, randomised trial” BJM Open, vol. 10, no. 3 (2020)