Actions of Dietary Tocotrienols on Obesity

Registry facts

Study at a glance

Phase

PHASE1, PHASE2

Enrollment

60 (ACTUAL)

Start date

2019-03-15

Sponsor

Texas Tech University Health Sciences Center

Design

RANDOMIZED · PARALLEL · PREVENTION

Locations

1

Results record

Not present in registry snapshot

Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Among these risk factors, obesity is now recognized as a worldwide epidemic disease. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. Aging and decline of estrogen are factors that contribute to weight gain in postmenopausal women, and approaches, such as anti-inflammatory potential in dietary antioxidants to reduce inflammation may likely combat obesity. Recent studies have indicated tocotrienols (one kind of vitamin E, a potent antioxidant) supplement may be good for mitigating negative impacts of obesity in postmenopausal women. However, no study has ever been done the role of tocotrienols in obesity-associated outcome measures in postmenopausal women. The long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for mitigating obesity in postmenopausal women. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. The investigators plan to enroll approximately 150-200 women to obtain 60 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols or tocotrienols group. The outcome measures will be assessed at baseline, after 12, and after 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. The investigators will monitor safety of subjects after 12 and after 24 weeks. Food intake and physical activity will be assessed at baseline, after 12, and after 24 weeks. All data will be analyzed statistically.