Tocotrienols for Obesity of Postmenopausal Women

NCT03705845 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: LBB18-147
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Postmenopausal Women

Outcome Measures

Primary Outcomes (2)

• Fat mass

  total and regional fat mass by DXA

  24 weeks

• visceral adipose tissue

  VAT by BIA

  24 weeks

Secondary Outcomes (10)

• total cholesterol

  24 weeks

• FASN

  24 weeks

• Oxylipins inflammation marker

  24 weeks

• Gut microbiota

  24 weeks

• hs-CRP

  24 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

ACTIVE COMPARATOR

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%

Interventions

placebo softgel DRUG

Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.

Also known as: olive oil

Control

DeltaGold® Tocotrienol 70% DRUG

DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% δ-tocotrienol + 10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.

Also known as: tocotrienols

Intervention

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (1)

• Aryaie A, Tinsley G, Lee J, Watkins BA, Moore L, Alhaj-Saleh A, Shankar K, Wood SR, Wang R, Shen CL. Actions of annatto-extracted tocotrienol supplementation on obese postmenopausal women: study protocol for a double-blinded, placebo-controlled, randomised trial. BMJ Open. 2020 Mar 8;10(3):e034338. doi: 10.1136/bmjopen-2019-034338.

  PMID: 32152169 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Olive Oil; Tocotrienols

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chwan-Li Shen, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: March 15, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)