Clinical trial

Tocotrienols for Obesity of Postmenopausal Women

Active, not recruiting · Phase 1, Phase 2 · 1 countries · Registry ID NCT03705845

Active, not recruitingPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexFemale

Healthy volunteersAccepted

ConditionObesity, Postmenopausal Women

Full registry criteria

Inclusion Criteria: 1. PMW with BMI ≥30 kg/m2. 2. Normal liver, kidney, and thyroid function (TSH)-sent to Quest Diagnostic Laboratory. 3. Sedentary using International Physical Activity Questionnaire (IPAQ-short form). Exclusion criteria 1. Unstable body weight (more than 5% change in body weight) within 3 months before intervention begins. 2. Changes to medications or supplements (i.e., steroids, statins) within 3 months of the baseline study visit that could affect lipid metabolism. • If they change any medications/supplements after the baseline visit that will affect lipid metabolism, their study participation will end. 3. Taking anticoagulants that may interact with TT. 4. Serious chronic disease (e.g., unstable cardiovascular disease, uncontrolled diabetes and hypertension, and active cancer).

Treatments and study arms

placebo softgel

Drug

Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.

DeltaGold® Tocotrienol 70%

Drug

DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% δ-tocotrienol + 10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.

Primary outcomes

Fat mass24 weeks

total and regional fat mass by DXA

visceral adipose tissue24 weeks

VAT by BIA

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Texas Tech University Health Sciences Center🇺🇸 Lubbock, Texas, United States

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