Effects of Alpha-GPC on Muscle Power, GH Levels, and Cognitive Function

Palo Alto (17 mi)

Overseen byTim Ziegenfuss, PhD

Age: 18 - 65

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Lindenwood University

Trial Summary

What is the purpose of this trial?Purpose: To determine the effects of low dose and high dose Alpha-GPC on cognitive performance, muscle performance, and serum growth hormone levels. Design: Randomized, three-arm, within-subject crossover Study Participants: 21 apparently healthy men to be recruited at a single investigational center in Northeast Ohio 4 Study Visits Study Visit 1: Participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet) Study Visit 2: Participants will ingest one of three supplements (a low dose α-GPC, a high dose α-GPC, or a placebo). Subjects will complete visual analog scale (VAS) questionnaires (assessing mood, motivation, alertness, and concentration) and a cognitive battery (Stroop, Flanker, and N-Back tests) 60 min post ingestion and approximately 3 hours post-ingestion, undergo upper body and lower body power testing and a lower body bout of moderate-intensity exercise 90 min post-ingestion. Also, subjects will undergo blood draws for levels of growth hormone at baseline (prior to supplementation) and 5, 15, 30, and 60 min post lower body bout of exercise. Vital signs and comprehensive side effect profile/ adverse event monitoring will take place throughout the duration of the study. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data. Study Visit 3 and 4 Identical to visit 2 with exception of different supplementation being provided. Supplement administration was randomized using a Latin square approach to reduce variability and enhance statistical power Primary Outcomes: Upper and lower body peak force production, peak power production, and peak velocity Secondary Outcomes: Cognitive performance on the Stroop test, Flanker, and N-Back test, serum growth hormone levels, mood, motivation, alertness, and concentration (as assessed by visual analog scales). Tertiary/Safety Outcomes: Vital signs, side effect profile/AE monitoring