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

NCT ID: NCT07267845

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2026-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dietary Supplement: 315 mg α-GPC

Group Type EXPERIMENTAL

Alpha-Glycerophosphocholine(α-GPC)

Intervention Type DIETARY_SUPPLEMENT

Participants will oral one capsule containing 350 mg of GeniusPure® (containing 315 mg of pure α-GPC) daily before breakfast for 6 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Microcrystalline Cellulose (placebo)

Intervention Type DIETARY_SUPPLEMENT

Participants will oral one capsule containing 350 mg of microcrystalline cellulose (MCC) daily before breakfast for 6 weeks.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline Cellulose (placebo)

Participants will oral one capsule containing 350 mg of microcrystalline cellulose (MCC) daily before breakfast for 6 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role collaborator

Nanjing Nutrabuilding Bio-tech Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlantia Clinical Trials

Cork, County Cork, Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Nontokozo Yusuff, MBChC

Role: CONTACT

+353 (0)21-430 7442

Facility Contacts

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Nontokozo Yusuff, MBChC

Role: primary

References

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Scientists help craft gene testing law. Science. 1996 Mar 1;271(5253):1235, 1237. No abstract available.

Reference Type RESULT
PMID: 11644786 (View on PubMed)

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.

Reference Type RESULT
PMID: 1428296 (View on PubMed)

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.

Reference Type RESULT
PMID: 37340479 (View on PubMed)

Other Identifiers

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NNB2025HCS-AFCRO-199

Identifier Type: -

Identifier Source: org_study_id

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