drugset / Trial / NCT03708354

Tocotrienols for Skeletal Muscle Health

NCT03708354

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2019-04-15
Primary completion
2022-12-31
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tocotrienol Small molecule 300 mg

Indications

No indication recorded.