Tocotrienols for Skeletal Muscle Health (NCT03708354) | Clinical Trial Compass
WithdrawnPhase 1/2
Tocotrienols for Skeletal Muscle Health
Stopped: Difficulties in Recruiting
United States0Started 2019-04-15
Plain-language 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.
Who can participate
Age range60 Years – 85 Years
SexFEMALE
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Inclusion criteria
✓. 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.