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NCT Number: NCT03705845

Tocotrienols for Obesity of Postmenopausal Women

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.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PMW with BMI ≥30 kg/m2.
  • Normal liver, kidney, and thyroid function (TSH)-sent to Quest Diagnostic Laboratory.
  • Sedentary using International Physical Activity Questionnaire (IPAQ-short form).

Exclusion criteria

  • Unstable body weight (more than 5% change in body weight) within 3 months before intervention begins.
  • 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.
  • Taking anticoagulants that may interact with TT.
  • Serious chronic disease (e.g., unstable cardiovascular disease, uncontrolled diabetes and hypertension, and active cancer).

Treatment and study plan

placebo softgel

Drug

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

Other names: olive oil

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.

Other names: tocotrienols

Primary outcomes

  1. Fat mass

    Time frame: 24 weeks

    total and regional fat mass by DXA

  2. visceral adipose tissue

    Time frame: 24 weeks

    VAT by BIA

Secondary outcomes

  1. total cholesterol

    Time frame: 24 weeks

    total cholesterol in serum

  2. FASN

    Time frame: 24 weeks

    Fatty acid synthase mRNA expression in fat tissue

  3. Oxylipins inflammation marker

    Time frame: 24 weeks

    oxylipins levels in plasma and adipose tissue

  4. Gut microbiota

    Time frame: 24 weeks

    abundance and composition of intestinal bacteria in feces

  5. hs-CRP

    Time frame: 24 weeks

    high-sensitivity C-reactive protein in serum

  6. leptin

    Time frame: 24 weeks

    serum leptin

  7. beta-oxidation

    Time frame: 24 weeks

    carnitine palmitoyltransferase 1A (CPT1) mRNA expression in adipose tissue

  8. endocannabinoids inflammatory markers

    Time frame: 24 weeks

    endocannabinoids levels in plasma and adipose tissue

  9. HDL

    Time frame: 24 weeks

    high density lipoprotein in serum

  10. TG

    Time frame: 24 weeks

    triglycerides in serum

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Actions of Dietary Tocotrienols on Obesity

Acronym: VitE-obesity

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2018
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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