Healthy Participants
Conditions
Keywords
Alpha-Glycerophosphocholine, α-GPC, cognitive function, sports performance, Dietary Supplement, safety
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAlpha-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.
DIETARY_SUPPLEMENTMicrocrystalline Cellulose (placebo)
Participants will oral one capsule containing 350 mg of microcrystalline cellulose (MCC) daily before breakfast for 6 weeks.
Sponsors
Atlantia Food Clinical Trials
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Performance - Stroop Test-Stroop total 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） | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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）. | Test the Reaction time variability (RTV) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo. |
| 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）. | Test the peak Velocity (m/s) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo on Vertical Jump for Lower Body Power (Tendo). |
| 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）. | Test the peak force production (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo on Vertical Jump for Lower Body Power (Tendo). |
| 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 mood assessed using the Visual Analog Scale (VAS), a 0-100 scale where 0 indicates 'worst mood imaginable' and 100 indicates 'best mood imaginable.' Higher scores represent better perceived mood. |
| 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）. | Perceived motivation assessed using the Visual Analog Scale (VAS), with a range of 0-100 where 0 indicates 'no motivation' and 100 indicates 'maximum motivation.' Higher scores represent better perceived motivation. |
| 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）. | Perceived energy assessed using the VAS, with a range of 0-100 where 0 indicates 'no energy' and 100 indicates 'maximum energy.' Higher scores represent better perceived energy. |
| 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） | 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) | 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 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) | 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 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 | 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 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 (%) | 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 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) | 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 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) | 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 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 (%) | 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 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 (%) | 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 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) | 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 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) | 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 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) | 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 Reaction time (mins) 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) | 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 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) | 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 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) | 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 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) | 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 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) | 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）. | 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. |
| 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）. | The peak power production (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. |
| 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）. | The peak velocity (m/s) 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. |
| 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）. | The peak force production (N) 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. |
| 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）. | Test the average power (W) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo on Vertical Jump for Lower Body Power (Tendo). |
| 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）. | Test the peak power production (W) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo on Vertical Jump for Lower Body Power (Tendo). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary Energy Intake | During baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）. | 24-Hour Dietary Intake using 24-hour recall approach.Dietary calorie intake(kcal) were evaluated. |
| Dietary macronutrient intake | During baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）. | 24-Hour Dietary Intake using 24-hour recall approach. Dietary macronutrient intake(g) were evaluated. |
| Temperature | During baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）. | Forehead temperature was measured using an electronic thermometer. |
| Heart Rate Measurement | Assessed at 0(before ingestion of assigned test product ), 60 and 190 min(after ingestion product) during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）. | Accurately measure heart rate using a dedicated heart rate monitor. |
| Blood Pressure Measurement (Systolic and Diastolic) | Assessed at 0(before ingestion of assigned test product ), 60 and 190 min(after ingestion product) during baseline（visit 2, week 1, day1） and end of the study（visit 3, week 6, day42）. | Blood pressure measured using an automated sphygmomanometer. Both systolic and diastolic pressures will be assessed. |
Countries
Ireland
Contacts
Primary ContactNontokozo Yusuff, MBChC
Outcome results
None listed