Effects of Alpha-GPC on Muscle Power, GH Levels, and Cognitive Function
NCT06690619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-11-15
Summary
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
Conditions
- Cognition - Other
- Strength Outcomes
Interventions
- DIETARY_SUPPLEMENT
-
Placebo
Maltodextrin
- DIETARY_SUPPLEMENT
-
315 mg Alpha-GPC
350 mg of 90% pure alpha-GPC (315 mg)
- DIETARY_SUPPLEMENT
-
630 mg Alpha-GPC
700 mg of 90% pure alpha-GPC (630 mg)
Sponsors & Collaborators
-
NNB Nutrition
collaborator UNKNOWN -
Lindenwood University
lead OTHER
Principal Investigators
-
Tim Ziegenfuss, PhD · Center for Applied Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 25 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-09
- Primary Completion
- 2024-06-11
- Completion
- 2024-06-11
Countries
- United States
Study Locations
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