Status:
COMPLETED
Evaluate the Effects of Citicoline on Cognitive Performance in Healthy Adults
Lead Sponsor:
Kirin Holdings Company, Limited
Collaborating Sponsors:
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Conditions:
Healthy
Cognitive Performance
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Cognizin is a patented form of citicoline, a natural compound of the brain tissue. It is believed that Cognizin can support brain function by boosting brain energy and protecting brain cells. Researc...
Detailed Description
This study is a prospective, randomized, placebo-controlled, double-blind trial designed to assess the effects of Cognizin on cognitive performance in healthy young adults. Participants will be rando...
Eligibility Criteria
Inclusion
- Healthy adult males and females who are 18-35 years of age (inclusive) at screening.
- Body mass index (BMI) between 18.0 to 34.9 kg/m2 (inclusive).
- In good general health and are able to swallow capsules.
- Participants agree to maintain their usual caffeine consumption habits.
- Participants who have habitually eaten breakfast for at least 1 month before screening, and agree to eat breakfast daily, and take study product with this meal when applicable as instructed, for the duration of the study.
- MMSE score \>24 at screening.
- Naïve to oral cannabis or hemp, or light user of oral cannabis or hemp products (not more than 2 times per month on average).
- Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study- related procedures.
Exclusion
- Females who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- Are receiving treatments, or have been hospitalized in the last 12 months, for psychiatric disorders and/or brain-related medical conditions.
- Participants who have habitually used any nicotine-containing products in the past 6 months before screening.
- Individuals with any pre-existing neuromuscular disorder, physical disability, or injury.
- Have inadequate sleep schedule defined as an average of less than 6 hours per night.
- Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease
- Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised.
- Currently have cancer or have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurred at least 5 years before the screening visit.
- Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing and digestion.
- Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product.
- Reports a clinically significant illness during the 28 days before the first dose of study product.
- Major surgery in 3 months prior to screening or planned major surgery during the study.
- Currently consumes more than two (2) standard alcoholic beverages per day on average for the two weeks prior to screening.
- Have a history of alcohol or substance abuse in the 12 months prior to screening
- Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer.
- Any other medical condition/situation or use of medications/ supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06906848
Start Date
November 20 2024
End Date
June 20 2025
Last Update
July 9 2025
Active Locations (1)
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1
Apex Trials
Guelph, Ontario - on, Canada, N1G 0B4