Effects of Alpha-GPC on Muscle Power, GH Levels, and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cognitive Performance-NBack
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistical analysis was masked
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Cognitive Performance-NBack
时间窗: Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4
The N Back cognitive performance test (https://www.lumosity.com/app/v4/games/speed-match-overdrive-web )
Cognitive Performance
时间窗: Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4
Flanker Cognitive Performance Test (https://www.psytoolkit.org/experiment-library/flanker.html)
次要结局
- 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)
- Perceived Alertness Assessment Using Visual Analog Scale (VAS)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4)
- Perceived Concentration Assessment Using Visual Analog Scale (VAS)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during visits 2, 3, and 4)
- Non-exertional Heart Rate Measurement(Assessed 60 minutes after ingestion of assigned test product and approximately 3.5 hours after ingestion during visits 2, 3, and 4)
- Non-exertional Blood Pressure Measurement (Systolic and Diastolic)(Assessed 60 minutes after ingestion of assigned test product and approximately 3.5 hours after ingestion during visits 2, 3, and 4)