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NCT03705845 · ClinicalTrials.gov registry record · Phase 1
Tocotrienols for Obesity of Postmenopausal Women
A Phase 1 study of Obesity and Postmenopausal Women, sponsored by Texas Tech University Health Sciences Center.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03705845: Active Phase 1 study of Obesity and Postmenopausal Women, sponsored by Texas Tech University Health Sciences Center.
NCT03705845 is a Phase 1 study of Obesity and Postmenopausal Women that is active but no longer recruiting, run by Texas Tech University Health Sciences Center. The registered enrollment target is 60 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03705845, a Phase 1 study of Obesity and Postmenopausal Women, is active but no longer recruiting, sponsored by Texas Tech University Health Sciences Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
total and regional fat mass by DXA
Conditions Studied
Interventions
- DRUG placebo softgel
- DRUG DeltaGold® Tocotrienol 70%
Study Locations (1)
Texas
- Texas Tech University Health Sciences Center - Lubbock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 1 |
What the registry record for NCT03705845 still lists
NCT03705845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which placebo softgel is the first listed.
NCT03705845 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03705845 about?
NCT03705845 is a clinical study titled "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) s...
What is the current status of trial NCT03705845?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2019-03-15. Estimated completion is 2025-12-30.
What conditions does trial NCT03705845 study?
This clinical trial studies the following conditions: Obesity, Postmenopausal Women.
What interventions are being tested in trial NCT03705845?
The interventions under investigation include: placebo softgel (DRUG), DeltaGold® Tocotrienol 70% (DRUG).
Who is sponsoring clinical trial NCT03705845?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03705845 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03705845's enrollment target sits among peer trials
60 642nd of 1053 higher than 374 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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