The Effect of α-GPC on Cognitive Function and Sports Performance
ConditionHealthy Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-55
SponsorNanjing Nutrabuilding Bio-tech Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Alpha-Glycerophosphocholine（α-GPC）
Dietary supplementParticipants will oral one capsule containing 350 mg of GeniusPure® (containing 315 mg of pure α-GPC) daily before breakfast for 6 weeks.
Microcrystalline Cellulose (placebo)
Dietary supplementParticipants will oral one capsule containing 350 mg of microcrystalline cellulose (MCC) daily before breakfast for 6 weeks.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Dietary Supplement: 315 mg α-GPCExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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.
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）2
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.
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）3
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.
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）4
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.
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）Other outcomes
1
Heart Rate Measurement
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）.2
Blood Pressure Measurement (Systolic and Diastolic)
Blood pressure measured using an automated sphygmomanometer. Both systolic and diastolic pressures will be assessed.
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）.3
Dietary Energy Intake
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）.4
Dietary macronutrient intake
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）.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Lead sponsor
Atlantia Food Clinical Trials
Collaborator
Source ClinicalTrials.gov