Atlantia Clinical Trials
Cork, County Cork, P56 W9X2, Ireland
Location status: Recruiting
NCT Number: NCT07267845
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.
Interested in participating?
Request Info25 year–55 year
All sexes
Interventional
Not applicable
Cork, County Cork, P56 W9X2, Ireland
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will oral one capsule containing 350 mg of GeniusPure® (containing 315 mg of pure α-GPC) daily before breakfast for 6 weeks.
Participants will oral one capsule containing 350 mg of microcrystalline cellulose (MCC) daily before breakfast for 6 weeks.
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)
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)
Test the stroop accuracy (%) 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)
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.
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)
Test the Number of Correct Symbols (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test the Total Correct Score change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test the Accuracy (%) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test the Time per Correct Response (s/item) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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).
Test the Go/No-Go - Correct responses (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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).
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.
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).
Test the Go/No-Go - Errors of commission (%) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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).
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.
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).
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.
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).
Test the Reaction time (mins) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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).
Test the Reaction time variability (RTV) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test total commission errors (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test omission errors (N) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test reaction time (Mean RT) change (Δ) from Day 1 to Day 42 in the α-GPC group compared to placebo.
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)
Test reaction time variability (RTV) change (Δ) from Day 1 to Day 42 effect in the α-GPC group compared to placebo on.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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).
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.
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).
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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Other
A Randomised, Double-Blind, Placebo-Controlled Study on the Effects of Alpha-Glycerophosphocholine (α-GPC) on Cognitive Function and Sports Performance in Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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