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临床试验/NCT07267845
NCT07267845招募中不适用

A Randomised, Double-Blind, Placebo-Controlled Study on the Effects of Alpha-Glycerophosphocholine (α-GPC) on Cognitive Function and Sports Performance in Adults

Nanjing Nutrabuilding Bio-tech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月21日最近更新:
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试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Cognitive Performance - Stroop Test-Stroop total score
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical trial is to find out whether daily supplementation with Alpha-Glycerophosphocholine (α-GPC) can improve cognitive function and sports performance in healthy adults. It will also assess the safety and tolerability of α-GPC when taken over a 6-week period.

The main questions this study aims to answer are:

Does taking α-GPC every day improve cognitive performance on tests such as the Stroop Test, Go/No-go Test, Sustained Attention to Response Task (SART), and Digit-Symbol Substitution Test (DSST)? Does α-GPC enhance upper and lower body sports performance? Does α-GPC positively affect perceived mood, energy, and motivation? Is α-GPC safe and well tolerated compared to a placebo? Researchers will compare α-GPC (350 mg per day) to a placebo (an inactive substance that looks the same) in a randomized, double-blind study. Neither the participants nor the researchers will know who receives α-GPC or the placebo.

Participants will:

Be randomly assigned to take either α-GPC or placebo capsules once daily for 6 weeks Attend 3 study visits over an 8-week period at Atlantia Clinical Trials in Cork, Ireland Complete cognitive and physical performance tests both acutely (shortly after a single dose) and after 6 weeks of daily use Have their vital signs, body weight, and any adverse events monitored throughout the study Record their diet and well-being during the study period This study will include 80 healthy adults aged 25-55 years who regularly engage in physical activity. The results will help determine whether α-GPC has benefits for brain function and physical performance, and whether it is safe for long-term use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Be able to give written informed consent.
  • •Be in good health as determined by the investigator.
  • •Age between 25 and 55 years (inclusive).
  • •Body Mass Index of 18.5-32.0 kg/m2 (inclusive).
  • •Body weight of at least 54 kilograms.
  • •Muscle strengthening activities 2-3 time per week or participation in recreational or local level moderate intensity activity for at least 2 years.
  • •Normotensive (resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg).
  • •Willing to duplicate their previous 24-hr diet, refrain from alcohol and caffeine for 24-hr prior to each visit, refrain from exercise 48-hr prior to each visit.
  • •Refrain from consuming beef liver, chicken liver, eggs, fish, wheat germ and soybeans, butter beans 24-hrs prior to Visit 2 and Visit 3.

排除标准

  • •Highly trained or competitive athletes.
  • •Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
  • •Female participants who are currently breastfeeding.
  • •Female participants who are planning to become pregnant during the study period.
  • •Female participants who test positive on a pregnancy test at screening or prior to first administration of the study product.
  • •Participants with history of drug and/or alcohol abuse at the time of enrolment. (Drinks more than nationally recommended units per week (>11 units for women; >17 units for men); alcohol/substance abuse disorder).
  • •Caffeine intake of three or more cups of coffee or equivalent (>400 mg) per day.
  • •Current smokers or users of any nicotine products in the past 4-weeks.
  • •Has food allergies or other issues with foods that would preclude intake of the Study Products.
  • •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
  • •History of malignancy in the previous 5 years except for non-melanoma skin cancer.
  • •Diagnosed, uncontrolled psychiatric disorder.
  • •Hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
  • •Prior gastrointestinal bypass surgery (excluding appendectomy).
  • •Gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism.
  • •Chronic inflammatory condition or disease.
  • •History of severe or chronic musculoskeletal pain or injury.
  • •History of diabetes, asthma, gout, fibromyalgia or clinical diagnosis of IBS/IBD.
  • •Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results as judged by the investigator.
  • •Use CNS stimulants or anxiety or ADHD medication.
  • •Use corticosteroids (oral, subcutaneous, intramuscular, or transdermal only).
  • •Use testosterone replacement therapy (ingestion, injection, or transdermal).
  • •Current or recent use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results as judged by the investigator.
  • •Use creatine, BCAA, HMB, betaine, beta-alanine, in the past 2 weeks.
  • •Use choline supplements (e.g. choline bitartrate, phosphatidylcholine, citicholine) in the past 4 weeks.
  • •Use omega-3, ginkgo biloba, ginseng, L-theanine, Lion's Mane, ashwagandha in the past 4 weeks.
  • •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
  • •Participants may be participating in other clinical studies.

结局指标

主要结局

Cognitive Performance - Stroop Test-Stroop total score

时间窗: Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）

Test the stroop total score change (Δ) of from Day 1 to Day 42 in the α-GPC group compared to placebo on Stroop Test.

次要结局

  • Cognitive Performance - Stroop Test - Stroop time per score (s)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive performance - Digit-Symbol Substitution Test (DSST) - Total Correct Score(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive Performance - Stroop Test - Stroop accuracy (%)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive performance - Digit-Symbol Substitution Test (DSST) - Number of Correct Symbols (N)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive Performance - Sustained Attention to Response Task (SART) - Omission Errors (N)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Upper Body Power - Peak force production (N)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Lower Body Power - Peak force production (N)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Perceived mood assessment(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Perceived motivation assessment(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Digit-Symbol Substitution Test (DSST) - Accuracy (%)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive performance - Go/No-go Test - Errors of commission (%)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Go/No-go Test - Mean response times (mins)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Go/No-go Test - Reaction time (mins)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Go/No-go Test- Reaction time variability (RTV)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Digit-Symbol Substitution Test (DSST) - Time per Correct Response (s/item)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive performance - Go/No-go Test - Correct responses (N)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Go/No-go Test - Errors of omissions (%)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive performance - Go/No-go Test - Correct rejections (N)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive Performance - Sustained Attention to Response Task (SART) - Total Commission Errors (N)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Cognitive Performance - Sustained Attention to Response Task (SART) - Reaction Time (Mean RT)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Upper Body Power - Average power (W)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Upper Body Power - Peak power production (W)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Upper Body Power - Peak Velocity (m/s)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Cognitive Performance - Sustained Attention to Response Task (SART) - Reaction Time Variability (RTV)(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）)
  • Lower Body Power - Average power (W)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Lower Body Power - Peak power production (W)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Lower Body Power - Peak Velocity (m/s)(Assessed 90 minutes after ingestion of assigned test product during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)
  • Perceived energy assessment(Assessed 60 minutes after ingestion of assigned test product and approximately 3 hours after ingestion during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）.)

研究者

发起方
Nanjing Nutrabuilding Bio-tech Co., Ltd.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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