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Tocotrienols for Obesity of Postmenopausal Women (Vit E-obesity)

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ClinicalTrials.gov Identifier: NCT03705845
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Postmenopausal Women Drug: placebo softgel Drug: DeltaGold® Tocotrienol 70% Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Actions of Dietary Tocotrienols on Obesity
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

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.
Drug: placebo softgel
Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.
Other Name: 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.
Drug: DeltaGold® Tocotrienol 70%
DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% δ-tocotrienol + 10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.
Other Name: tocotrienols




Primary Outcome Measures :
  1. Fat mass [ Time Frame: 24 weeks ]
    total and regional fat mass by DXA

  2. visceral adipose tissue [ Time Frame: 24 weeks ]
    VAT by BIA


Secondary Outcome Measures :
  1. total cholesterol [ Time Frame: 24 weeks ]
    total cholesterol in serum

  2. FASN [ Time Frame: 24 weeks ]
    Fatty acid synthase mRNA expression in fat tissue

  3. Oxylipins inflammation marker [ Time Frame: 24 weeks ]
    oxylipins levels in plasma and adipose tissue

  4. Gut microbiota [ Time Frame: 24 weeks ]
    abundance and composition of intestinal bacteria in feces

  5. hs-CRP [ Time Frame: 24 weeks ]
    high-sensitivity C-reactive protein in serum

  6. leptin [ Time Frame: 24 weeks ]
    serum leptin

  7. beta-oxidation [ Time Frame: 24 weeks ]
    carnitine palmitoyltransferase 1A (CPT1) mRNA expression in adipose tissue

  8. endocannabinoids inflammatory markers [ Time Frame: 24 weeks ]
    endocannabinoids levels in plasma and adipose tissue

  9. HDL [ Time Frame: 24 weeks ]
    high density lipoprotein in serum

  10. TG [ Time Frame: 24 weeks ]
    triglycerides in serum



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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) during the past 3 months.
  2. Taking medications (i.e., steroid) or supplements that could affect lipid metabolism or attempt for weight loss during the past 3 months.
  3. Taking supplements (i.e., fish oil) that have anti-inflammatory action during the past 3 months.
  4. Taking anticoagulants that may interact with TT.
  5. Serious chronic disease (e.g., unstable CVD, uncontrolled diabetes and hypertension, and active cancer).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705845


Contacts
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Contact: Chwan-Li Shen, PhD 8067432815 leslie.shen@ttuhsc.edu

Locations
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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Chwan-Li Shen, PhD Texas Tech University Health Sciences Center

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT03705845     History of Changes
Other Study ID Numbers: LBB18-147
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tocotrienols
Vitamin E
Tocopherols
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances