Weakness, Muscle Clinical Trial
Official title:
Effects of INDUS810 on Body Composition, Muscular Performance, and Training Adaptations During 12-weeks of Supplementation and Concurrent Training
The purpose of this 12-week, interventional study is to determine the effects of oral supplementation with Indus810 (dietary supplement with active ingredient Fenugreek) on body composition, muscular performance, and training adaptations
This 12-week study is a randomized, parallel-group, placebo-controlled, clinical trial of
N=66 recreationally, but normal to moderately overweight/obese male subjects to be recruited
at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health
Sciences).
Subjects will attend 4 study visits. At Visit 1, subjects will be screened for participation
(i.e., medical history, physical exam, routine blood work, background baseline diet). At
Visits 2 (day 0 - Baseline Testing), and 4 (week 12), measurements of various hemodynamic,
hematologic & biochemical biomarkers of safety (Total testosterone, CBC, and comprehensive
metabolic panel) will be made. At Visits 2, 3, and 4, the following efficacy measures will be
obtained: Body Composition assessment via DEXA, Upper and Lower Body Performance testing on a
Smith Machine and a TENDO unit utilizing the bench press and squat exercises, and anchored
100mm VAS scales (for various psychometric indices). In addition, a comprehensive side effect
profile/ adverse event monitoring will take place throughout the 12-week study duration.
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