This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.
This study will be an open label, uncontrolled, ascending dose clinical trial to assess the tolerance and effect of orally ingested Musclin, 20 mg thymol per capsule, in healthy adult subjects. In addition, this study will evaluate whether Musclin has an effect on creatine kinase and myostatin levels. The study will aim to enroll 20 consenting men and women. Consented subjects will ingest 2 capsules of Musclin daily for 30 days and increase to 4 capsules daily for an additional 30 days . Physical assessments and biological samples will be collected at baseline (day 0) and at end of treatment (d 60). Surveys to include reported stamina and energy levels will be collected at baseline, prior to increased dosage (d 30) and end of treatment period. Risk to participants is expected to be minimal and will be outlined through an informed consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Musclin - a dietary supplement: 2 capsules (20 mg thymol per capsule) BID with a meal for 30 days increased to 4 capsules for an additional 30 days.
Palm Beach Research Center
West Palm Beach, Florida, United States
RECRUITINGNumber of Participants with adverse events as a measure of tolerance
Time frame: Day 60 (End of Study)
Change in creatinine kinase
Change in creatinine kinase measured in U/L
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Change in myostatin levels
Change in myostatin will be measured by blood samples using ELISA method.
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Changes in weight
Effect of supplement on weight (lbs)
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Change in cholesterol levels
Effect of supplement on cholesterol levels
Time frame: Day 1(Baseline) to Day 60 (End of Study)
Number, type, and severity of adverse events
Time frame: 60 days
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