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Vitamin E Supplement

Tocotrienols for Obesity (VitE-obesity Trial)

Phase 1 & 2
Recruiting
Led By Chwan-Li Shen, PhD
Research Sponsored by Texas Tech University Health Sciences Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

VitE-obesity Trial Summary

This trial is testing whether taking a supplement called tocotrienols (a kind of vitamin E) for 24 weeks can help reduce negative impacts of obesity in postmenopausal women, by looking at different measurements related to obesity.

Who is the study for?
This trial is for postmenopausal women with obesity (BMI ≥30 kg/m2) who are generally inactive. They must have stable body weight and not be taking medications or supplements that affect lipid metabolism. Women with serious chronic diseases or those on anticoagulants that may interact with tocotrienols cannot participate.Check my eligibility
What is being tested?
The study tests if a form of vitamin E called DeltaGold® Tocotrienol can help reduce the negative effects of obesity in postmenopausal women over 24 weeks, compared to a placebo. Participants will be randomly assigned to either the tocotrienol group or a placebo group.See study design
What are the potential side effects?
While specific side effects are not listed, as tocotrienols are a type of vitamin E and an antioxidant, potential side effects could include stomach discomfort, fatigue, headache, rash or bruising more easily.

VitE-obesity Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat mass
visceral adipose tissue
Secondary outcome measures
FASN
Gut microbiota
HDL
+7 more

VitE-obesity Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
One 430 mg tocotrienol softgel daily for 24 weeks. Each tocotrienol softgel (DeltaGold® Tocotrienol 70%) contains 430 mg tocotrienol (90% δ-tocotrienol+10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.
Group II: ControlPlacebo Group1 Intervention
One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor
104 Previous Clinical Trials
10,714 Total Patients Enrolled
10 Trials studying Obesity
466 Patients Enrolled for Obesity
Chwan-Li Shen, PhDPrincipal InvestigatorTexas Tech University Health Sciences Center
1 Previous Clinical Trials

Media Library

DeltaGold® Tocotrienol 70% (Vitamin E Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03705845 — Phase 1 & 2
Obesity Research Study Groups: Control, Intervention
Obesity Clinical Trial 2023: DeltaGold® Tocotrienol 70% Highlights & Side Effects. Trial Name: NCT03705845 — Phase 1 & 2
DeltaGold® Tocotrienol 70% (Vitamin E Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705845 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals are researchers aiming to accomplish with this clinical trial?

"This 24-week clinical trial aims to evaluate visceral adipose tissue. Secondary objectives are the quantification of oxylipins as an inflammation marker, beta-oxidation via carnitine palmitoyltransferase 1A (CPT1) mRNA expression in adipose tissue and endocannabinoids levels in plasma and adipose tissue."

Answered by AI

How many individuals are participating in this research endeavor?

"Affirmative. The clinicaltrials.gov website reveals that this research is still open for recruitment, having first been published on March 15th 2019 and recently updated on February 2nd 2022. 60 participants have the opportunity to join at a single site."

Answered by AI

Is this a pioneering clinical trial?

"Currently, 11 studies pertaining to Intervention are running across 22 cities in 4 different nations. This program of research was launched by Pronova BioPharma back in 2017 and included 174 trial participants who completed Phase 3 drug approval. Over the span of four years, 37 separate trials have been carried out for this investigation."

Answered by AI

What other experimental treatments have been tested with Intervention?

"Currently, 11 clinical trials for Intervention are active with 3 in Phase 3. These studies have been established at 31 different locations, particularly concentrated around Mexico City."

Answered by AI

Are recruitment efforts still being made for this experiment?

"According to the information recorded on clinicaltrials.gov, this research trial is still actively recruiting patients after being publishedon March 15th 2019 and revised recently on February 2nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Tech University Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m obese and nothing I do to lose weight seems to be working and it’s starting to effect my health.
PatientReceived 2+ prior treatments
Recent research and studies
BMJ OpenJournal
Actions of Annatto-extracted Tocotrienol Supplementation on Obese Postmenopausal Women: Study Protocol for a Double-blinded, Placebo-controlled, Randomised Trial
Aryaie, Amir, Grant Tinsley, Jaehoon Lee, Bruce A Watkins, Lane Moore, Adel Alhaj-Saleh, Kartik Shankar, Sarah R Wood, Rui Wang, and Chwan-Li Shen. 2020. “Actions of Annatto-extracted Tocotrienol Supplementation on Obese Postmenopausal Women: Study Protocol for a Double-blinded, Placebo-controlled, Randomised Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2019-034338.
clinicaltrials.govStudy
Tocotrienols for Obesity of Postmenopausal Women
2019. "Tocotrienols for Obesity of Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03705845.
~10 spots leftby Apr 2025
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