Tocotrienols for Obesity of Postmenopausal Women

Phase 1

Active, not recruiting

• Conditions: Obesity; Postmenopausal Women
• Interventions: Drug: DeltaGold® Tocotrienol 70%; Drug: placebo softgel

• Registration Number: NCT03705845
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-15
• Study Start: 2019-03-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-12-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	DeltaGold® Tocotrienol 70%	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.
Control	placebo softgel	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.

Primary Outcome Measures

Name	Time	Method
visceral adipose tissue	24 weeks	VAT by BIA
Fat mass	24 weeks	total and regional fat mass by DXA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States