Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Lindenwood University
With
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).
Age
25–55
Sex
MALE
Healthy volunteers
Accepted
