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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06690619 on ClinicalTrials.gov