Tocotrienols for Obesity of Postmenopausal Women

Study acronym: VitE-obesity
StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Study completion pushed from Dec 30, 2025 to Dec 30, 2027
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 1 of 1 entry
  2. Study completion date: Aug 30, 2025 to Dec 30, 2025v15
  3. Primary completion date: Nov 30, 2023 to Dec 30, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 30, 2023 to Aug 30, 2025
    • Site details revised
    v14
  4. Re-verified, no change to tracked fieldsv13
  5. Primary completion date: Nov 30, 2022 to Nov 30, 2023
    • Study completion date: Dec 30, 2022 to Dec 30, 2023
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2019 to Mar 15, 2019
    • Site details revised
    v10
  3. Eligibility criteria expanded, about 8 wordsv9
  4. Start date: Sep 15, 2019 to Dec 15, 2019v8
  5. Start date: Aug 15, 2019 to Sep 15, 2019
    • Primary completion date: Sep 30, 2022 to Nov 30, 2022
    • Study completion date: Sep 30, 2022 to Dec 30, 2022
    v7
  6. Start date: Jun 15, 2019 to Aug 15, 2019v6
  7. Start date: Mar 15, 2019 to Jun 15, 2019v5
  8. Start date: Dec 15, 2018 to Mar 15, 2019v4
  9. Start date: Nov 15, 2018 to Dec 15, 2018v3
  10. Start date: Oct 15, 2018 to Nov 15, 2018v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03705845
Lead Sponsor Texas Tech University Health Sciences Center
Conditions
(from sponsor)		 Obesity, Postmenopausal Women
Related terms Obesity
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov