NCT07267845 - The Effect of α-GPC on Cognitive Function and Sports Performance | Crick

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Cognitive Performance - Stroop Test-Stroop total score

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.

Time frame: 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）

Secondary Outcomes

Cognitive Performance - Stroop Test - Stroop accuracy (%)

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

Cognitive Performance - Stroop Test - Stroop time per score (s)

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

Cognitive performance - Digit-Symbol Substitution Test (DSST) - Number of Correct Symbols (N)

Test the Number of Correct Symbols (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Digit-Symbol Substitution Test (DSST) - Total Correct Score

Test the Total Correct Score change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Digit-Symbol Substitution Test (DSST) - Accuracy (%)

Test the Accuracy (%) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Digit-Symbol Substitution Test (DSST) - Time per Correct Response (s/item)

Test the Time per Correct Response (s/item) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test - Correct responses (N)

Test the Go/No-Go - Correct responses (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test - Errors of omissions (%)

Test the Go/No-Go - Errors of omissions (%) change (Δ) from Day 1 to Day 42 effect in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test - Errors of commission (%)

Test the Go/No-Go - Errors of commission (%) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test - Correct rejections (N)

Test the Go/No-Go - Correct rejections (N) change (Δ) from Day 1 to Day 42 effect in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test - Mean response times (mins)

Test the Go/No-Go - Mean response times (mins) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test - Reaction time (mins)

Test the Reaction time (mins) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive performance - Go/No-go Test- Reaction time variability (RTV)

Test the Reaction time variability (RTV) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive Performance - Sustained Attention to Response Task (SART) - Total Commission Errors (N)

Test total commission errors (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive Performance - Sustained Attention to Response Task (SART) - Omission Errors (N)

Test omission errors (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive Performance - Sustained Attention to Response Task (SART) - Reaction Time (Mean RT)

Test reaction time (Mean RT) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.

Cognitive Performance - Sustained Attention to Response Task (SART) - Reaction Time Variability (RTV)

Test reaction time variability (RTV) change (Δ) from Day 1 to Day 42 effect in the α-GPC group compared to placebo on.

Upper Body Power - Average power (W)

The average power (W) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to the Placebo group will be assessed by Ballistic Smith Machine Bench Press.