Tocotrienols for Skeletal Muscle Health

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Dynapenia, Postmenopausal Women

In brief

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.

Key facts

Study ID

NCT03708354

Run by

Texas Tech University Health Sciences Center

People needed

0

Starts

2019-04-15

Expected to finish

2022-12-31

Last updated by the study team

2022-02-18

Who can join

Age: 60 and older, up to 85. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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