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

NCT06690619 | Completed

• 1 other identifier: NNB-001-012024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cognition; Mental Acuity; Performance; Nootropic; Mental; Acute supplementation

Outcome Measures

Primary Outcomes (3)

• Cognitive Performance-NBack

  The N Back cognitive performance test (https://www.lumosity.com/app/v4/games/speed-match-overdrive-web )

  Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4

• Cognitive Performance

  Flanker Cognitive Performance Test (https://www.psytoolkit.org/experiment-library/flanker.html)

  Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4

• Cognitive Performance

  Stroop Color Matching Test

  Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4

Secondary Outcomes (9)

• Lower Body Power

  Assessed 90 minutes post-ingestion during each study visit

• Upper Body Power

  Assessed 90 minutes post-ingestion during each study visit

• Growth Hormone

  Assessed before exercise and 5, 15, 30, and 60 minutes after exercise during visits 2, 3, and 4

• Perceived mood assessed using visual analog scale

  Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4

• Perceived motivation assessment using visual analog scales

  Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4

Other Outcomes (2)

• Percent Body Fat

  At baseline (Visit 1), at the start of the study.

• Dietary Intake

  Day 1, Day 8, and Day 15

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Low Dose Alpha-GPC

ACTIVE COMPARATOR

315 mg dose of alpha-glycerylphosphorycholine (alpha-GPC)

Dietary Supplement: 315 mg Alpha-GPC

High Dose Alpha-GPC

ACTIVE COMPARATOR

630 mg dose of alpha-glycerylphosphorycholine (alpha-GPC)

Dietary Supplement: 630 mg Alpha-GPC

Interventions

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

315 mg Alpha-GPC DIETARY_SUPPLEMENT

350 mg of 90% pure alpha-GPC (315 mg)

Low Dose Alpha-GPC

630 mg Alpha-GPC DIETARY_SUPPLEMENT

700 mg of 90% pure alpha-GPC (630 mg)

High Dose Alpha-GPC

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• Lindenwood University: lead
• NNB Nutrition: collaborator

Study Sites (1)

Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Related Publications (1)

• Kerksick CM. Acute Alpha-Glycerylphosphorylcholine Supplementation Enhances Cognitive Performance in Healthy Men. Nutrients. 2024 Dec 9;16(23):4240. doi: 10.3390/nu16234240.

  PMID: 39683633 DERIVED

Study Officials

• Tim Ziegenfuss, PhD

  Center for Applied Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistical analysis was masked
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N/A. Full detail provided in Study Description

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: January 9, 2024
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)