Tocotrienols for Obesity of Postmenopausal Women (VitE-obesity)

Actions of Dietary Tocotrienols on Obesity

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Chwan-Li (Leslie) Shen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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.
Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.
Other Names:
  • olive oil
Active Comparator: 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.
DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% δ-tocotrienol + 10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.
Other Names:
  • tocotrienols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: 24 weeks
total and regional fat mass by DXA
24 weeks
visceral adipose tissue
Time Frame: 24 weeks
VAT by BIA
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total cholesterol
Time Frame: 24 weeks
total cholesterol in serum
24 weeks
FASN
Time Frame: 24 weeks
Fatty acid synthase mRNA expression in fat tissue
24 weeks
Oxylipins inflammation marker
Time Frame: 24 weeks
oxylipins levels in plasma and adipose tissue
24 weeks
Gut microbiota
Time Frame: 24 weeks
abundance and composition of intestinal bacteria in feces
24 weeks
hs-CRP
Time Frame: 24 weeks
high-sensitivity C-reactive protein in serum
24 weeks
leptin
Time Frame: 24 weeks
serum leptin
24 weeks
beta-oxidation
Time Frame: 24 weeks
carnitine palmitoyltransferase 1A (CPT1) mRNA expression in adipose tissue
24 weeks
endocannabinoids inflammatory markers
Time Frame: 24 weeks
endocannabinoids levels in plasma and adipose tissue
24 weeks
HDL
Time Frame: 24 weeks
high density lipoprotein in serum
24 weeks
TG
Time Frame: 24 weeks
triglycerides in serum
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chwan-li Shen, PhD, Texas Tech University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 12, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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