- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705845
Tocotrienols for Obesity of Postmenopausal Women (VitE-obesity)
April 10, 2023 updated by: Texas Tech University Health Sciences Center
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Chwan-Li Shen, PhD
- Phone Number: 8067432815
- Email: leslie.shen@ttuhsc.edu
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79430
- Recruiting
- Texas Tech University Health Sciences Center
-
Contact:
- Chwan-Li (Leslie) Shen, PhD
- Phone Number: 806-743-2815
- Email: Leslie.Shen@ttuhsc.edu
-
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:
- 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).
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:
|
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBB18-147
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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