Tocotrienols for Skeletal Muscle Health

NCT03708354 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: L19-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia, defined as a reduction in muscle mass and strength, is a major health concern for postmenopausal women. Evidence suggests that lowering inflammation levels is an important strategy to help mitigate age-related muscle dysfunction and loss. In this pilot study, the investigators will study a tocotrienol (vitamin-E isomer) intervention for feasibility and quantify its effects on postmenopausal women with low muscle strength. A double blind, placebo controlled trial will be conducted on fifty-two qualified subjects. The participants will be assigned to placebo or tocotrienols for 24 weeks. All participants will receive an Omron Alvita Optimized Pedometer. The investigators will measure muscular endurance, strength, and size and gut microbiome profiles at 0, 12, and 24 weeks. In addition, the investigators will measure serum and muscle inflammatory levels at 0 and 24 weeks. All data will be analyzed statistically at p\<0.05.

Conditions

Dynapenia; Postmenopausal Women

Keywords

skeletal muscle strength

Outcome Measures

Primary Outcomes (1)

• lower-body muscle endurance

  assessed by 6-min walk test

  24 weeks

Secondary Outcomes (11)

• 8-OHdG

  24 weeks

• oxylipins

  24 weeks

• gut microbiome

  24 weeks

• handgrip strength

  24 weels

• lower-body muscle strength

  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

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.

Also known as: olive oil

Control

DeltaGold® Tocotrienol 70% DRUG

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

Also known as: tocotrienol

Intervention

Eligibility Criteria

• Age: 60 Years - 85 Years
• Gender Eligibility Details: Aging and decline of estrogen are factors that contribute to skeletal muscle disorders in postmenopausal women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (60-85 yr) not on hormone replacement therapy in the past year.
• Normal liver, kidney, thyroid function (TSH), serum 25-OH vitamin D (≥ 20 ng/ml)-sent to Quest Diagnostic Laboratory.
• Grip strength weakness (\<20 kg).
• Sedentary -evaluated by using self-administered International Physical Activity Questionnaire (IPAQ) short form.

You may not qualify if:

• Serious chronic disease (e.g., unstable CVD, uncontrolled diabetes, uncontrolled hypertension, active cancer, Parkinson's disease).
• Taking hormone replacement therapy within 3 months before study starts.
• Taking medications (i.e., steroids) within 3 months before study starts, since steroids could affect muscle function.
• Taking supplements (i.e., fish oil) that have anti-inflammatory action during the past 3 months.
• Having dementia or other medical/eating disorder (i.e. currently receiving an appetite stimulant).
• Self-report of \>10% body weight loss in the past month.
• Taking anticoagulants that may interact with tocotrienols.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Interventions

Olive Oil; Tocotrienols

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
• Masking Details: Placebo softgels will be of the same size/color as the active softgels.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: dietary supplement

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 17, 2018
• Study Start: April 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)