Clinical Trial

Tocotrienols for Obesity of Postmenopausal Women

Study acronym: VitE-obesity
Active, Not Recruiting Phase 1/2
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Summary
Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. 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. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators will enroll 60 qualified women at the start of the study and randomly assigned to no tocotrienols (placebo) or tocotrienols group for 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. All data will be analyzed statistically.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2018-10-12; most recent amendment 2025-03-27.
Status change: Recruiting → Active, Not Recruiting 2024-08-02
Status change: Not Yet Recruiting → Recruiting 2020-01-15
Trial Details
NCT Number NCT03705845
Lead Sponsor Texas Tech University Health Sciences Center
Conditions Obesity, Postmenopausal Women
Enrollment 60 participants
Start Date 2019-03-15
Primary Completion 2024-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-28