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

DIET:

• All subjects will be asked to maintain their usual dietary habits throughout the study.
• At screening, all subjects will complete a 24-hour diet recall from the day prior while refraining from any nutrients that might affect choline.
• To replicate screening conditions as closely as possible, subjects will follow their previously recorded 24-hour diet record and fast for 8 hours prior to each laboratory visit.
• An online application (Nutritionix) will be used to analyze their dietary consumption.

BLOODWORK:

•Blood draws will take place during each laboratory visit, and they will be performed by a study nurse or phlebotomist. At screening a single blood draw will be performed with a total blood volume of approximately 12 mL. During visits 2-4 serial blood draws will be performed before and 5-, 15-, 30-, and 60-min post ingestion of the investigational product. During visits 2-4, an intra-venous catheter (flexible tubing to enable blood sampling) will be inserted into an upper extremity vein. Blood samples will be collected up to 5 times over 4 hours.

EXERCISE TRAINING AND PHYSICAL ACTIVITY CONTROL

•Subjects will be asked to maintain their activities of daily living and abstain from exercise for 48 hours prior to each trial.

TEST PRODUCTS

• After qualifying for the study, subjects will be randomly assigned to receive a placebo, a low dose of α-GPC, and a high dose of α-GPC using a Latin Square design.
• Low dose of α-GPC (350 mg)
• High dose of α-GPC (700 mg)
• Placebo (containing maltodextrin)
• Supplements will be provided in identical-looking capsules with label directions and Study Protocol Number.
• Subjects will consume each supplement in the presence of the medical staff.
• There will be no less than one week between each trial, though this may be longer depending on scheduling.
• As stated earlier, subjects who withdraw from the study prior to completing all three trials may be replaced.

DETAILED STUDY PROCEDURES

Visit 1 (Screening)

• Medical history, safety blood work (CBC, CMP, and Lipid Panel)
• Body composition (bioimpedance-BIA)
• Baseline diet (24hr recall).
• Body weight
• Familiarization trial for the cognitive battery (Stroop, Flanker, and N-Back test).

Visits 2-4

• Subjective feelings of mood, motivation, alertness, and concentration will be assessed 60 minutes post ingestion and approximately 3 hours post-ingestion. All assessments will be made using 100 mm anchored visual analogue scales (VAS).
• Three repetitions of the Stroop (2-min tests), Flanker, and N-Back (90s tests) tests will be assessed 60 minutes post ingestion and approximately 3 hours post-ingestion.
• Stroop - https://www.psytoolkit.org/lessons/stroop.html
• Flanker - https://www.psytoolkit.org/experiment-library/flanker.html
• N-Back - https://www.lumosity.com/app/v4/games/speed-match-overdrive-web
• Upper and lower body muscular power will be assessed with a Tendo unit. For the upper body, the bench press throw using a submaximal load (i.e., 50% of 1RM) will be performed on a Smith machine. For the lower body, a vertical jump will be performed. Both tests will be performed 90 minutes post-ingestion.
• Moderate intensity lower body exercise bout consisting of 6 sets of 10 repetitions at 70% of 1RM of squats using a metronome for cadence (15 reps per min) on a Smith machine approximately 2 hours post-ingestion.
• Growth hormone will be measured via blood draw before supplementation ingestion and 5, 15, 30, and 60 min post lower body exercise bout.
• Body weight
• Vital signs will be assessed prior to supplementation, 60 minutes post ingestion, and approximately 3.5 hr post-ingestion.

Study Schematic:

Informed Consent: Visit 1 Inclusion/Exclusion Criteria: Visit 1 Medical History: Visit 1 Height, weight, and BMI: Visits 1, 2, 3, 4 24-hr Dietary recall: Visit 1 CBC, CMP, Lipid Panel: Visit 1 Vitals (HR and BP): Visit 1 Bioimpedance Analysis (BIA) for percent body fat: Visit 1 Bench Press Throw for Upper Body Power (Tendo) @ 50%1RM approximately 90 minutes post-ingestion: Visits 2, 3, 4 Vertical Jump for Lower Body Power (Tendo) approximately 90 minutes post-ingestion: Visits 2, 3, 4 Lower body exercise bout consisting of squats on a Smith machine (6 x 10 @70%1RM) beginning approximately 2 hours post-ingestion: Visits 2, 3, 4 Cognitive performance battery (N-back, Flanker, Stroop) (60 min post ingestion and approximately 3 hours post-ingestion on visits 2-4 only): Visits 1, 2, 3, 4 Serum GH (before ingestion and 5, 15, 30, and 60 min post lower body exercise bout): Visits 1, 2, 3, 4 VAS (mood, motivation, alertness, and concentration) 60 min post ingestion and approximately 3 hours post-ingestion): Visits 2, 3, 4 Vitals (HR and BP) monitoring (at baseline, 60 min post ingestion, and approximately 3.5 hours post-ingestion): Visits 2, 3, 4 24 hr Diet Records/Analysis/Repeat: Visits 2, 3, 4 Protocol Compliance (diet and physical activity log check): Visits 2, 3, 4 Dispense Test Product: Visits 2, 3, 4 Adverse Events Monitoring: Visits 1, 2, 3, 4

METHODS AND INSTRUMENTATION:

• Health history will be determined using a standardized (IRB-approved) questionnaire.
• Heart rate and blood pressure will be measured using an automated sphygmomanometer.
• Body composition will be measured using a bioimpedance device (InBody 570- https://inbodyusa.com/products/inbody570/).
• Standing height will be determined using a wall-mounted stadiometer.
• Body weight and height will be measured using a Seca Medical Scale (https://www.hogentogler.com/seca/769-physician-scale.asp?gclid=EAIaIQobChMIxoqxi6ef8wIVtmpvBB34QAwzEAQYAyABEgIVIPD_BwE).
• Upper and lower body muscular power will be determined using a Tendo power analyzer (Tendo Sport- https://www.tendosport.com/products/tendo-unit/overview/)
• A Central Lab (LabCorp, Dublin, OH) will be utilized to transport and analyze all blood samples.
• Diet records will be analyzed using the online application (Nutritionix).