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

Completed · Not applicable · Has a placebo group

Conditions studied: Cognition - Other, Strength Outcomes

In brief

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

Key facts

Study ID

NCT06690619

Run by

Lindenwood University

People needed

20

Starts

2024-01-09

Expected to finish

2024-06-11

Last updated by the study team

2024-11-15

Who can join

Age: 25 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Voluntarily provide signed and dated informed consent.
• Be in good health as determined by medical history and routine blood chemistries.
• Age between 25 and 55 years (inclusive).
• Body Mass Index of 18.5-34.9 (inclusive).
• Body weight of at least 120 pounds.
• Resistance training history of at least 2 years.
• Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg.
• Normal supine, resting heart rate (< 90 per minute).
• Willing to duplicate their previous 24-hour diet, refrain from alcohol and caffeine for 24 hr prior to each trial, refrain from exercise 48 hr prior to each trial, refrain from any nutrients that might affect choline 24 hr prior to each trial, and fast for 8 hours prior to each trial.

You may not qualify if…

• Highly trained or competitive athletes.
• History of diabetes, asthma, gout, fibromyalgia or clinical diagnosis of IBS/IBD.
• History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• History of psychiatric disorder.
• History of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• Use of any dietary supplements that may confound the study or its endpoints, including creatine, BCAA, HMB, betaine, beta-alanine, etc.
• Use of stimulants or anxiety or ADHD medication.
• Caffeine intake of three or more cups of coffee or equivalent (>400 mg) per day.
• Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
• Smokers.
• Clinically significant abnormal laboratory results at screening.
• Prior gastrointestinal bypass surgery (Lapband, etc.).
• Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Concomitant use of corticosteroids or testosterone replacement therapy (ingestion, injection, or transdermal).
• Known allergy or sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
• Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
• Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.

Where it is running

• Center for Applied Health Sciences — Canfield, Ohio, United States

Full record on ClinicalTrials.gov

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