The Effect of α-GPC on Cognitive Function and Sports Performance

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Alpha-Glycerophosphocholine（α-GPC）
  Participants will oral one capsule containing 350 mg of GeniusPure® (containing 315 mg of pure α-GPC) daily before breakfast for 6 weeks.
• Пищевая добавка Microcrystalline Cellulose (placebo)
  Participants will oral one capsule containing 350 mg of microcrystalline cellulose (MCC) daily before breakfast for 6 weeks.

Первичные конечные точки

• Cognitive Performance - Stroop Test-Stroop total score [Срок оценки: 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）]

Вторичные конечные точки (12)

• Cognitive Performance - Stroop Test - Stroop accuracy (%) [Срок оценки: 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 time per score (s) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 (%) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 (%) [Срок оценки: 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 (%) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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）.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Ирландия · 1 центр

• Atlantia Clinical Trials — Cork

Публикации

• 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
• Gatti G, Barzaghi N, Acuto G, Abbiati G, Fossati T, Perucca E. A comparative study of free plasma choline levels following intramuscular administration of L-alpha-glycerylphosphorylcholine and citicoline in normal volunteers. Int J Clin Pharmacol Ther Toxicol. 1992 Sep;30(9):331-5. PMID 1428296
• Yamashita S, Kawada N, Wang W, Susaki K, Takeda Y, Kimura M, Iwama Y, Miura Y, Sugano M, Matsuoka R. Effects of egg yolk choline intake on cognitive functions and plasma choline levels in healthy middle-aged and older Japanese: a randomized double-blinded placebo-controlled parallel-group study. Lipids Health Dis. 2023 Jun 20;22(1):75. doi: 10.1186/s12944-023-01844-w. PMID 37340479

Идентификаторы

NCT: NCT07267845 · NNB2025HCS-AFCRO-199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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