What is citicoline studying for mood in healthy adults?

Citicoline is being studied to see how it affects mood in healthy men and women aged 21 to 65. Researchers want to understand if taking citicoline can improve mood compared to a placebo. This trial is sponsored by Kirin Holdings Company, Limited and uses careful testing to evaluate these effects.

Who may be eligible for this healthy adult clinical trial?

Adults between 21 and 65 years old in good health who experience moderate mood disturbance may be eligible. Both men and women can participate, but pregnant or lactating women are excluded. People using certain supplements or medications, or with specific medical conditions, may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult clinical trial?

Study-related care, including the study supplement and all trial visits, is provided at no cost. However, any personal travel or related expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for their own transportation or accommodation needs.

Actively Recruiting

Phase Not Applicable

Age: 21Years - 65Years

All Genders

Healthy Volunteers

ID07089238

Study of Oral Citicoline Supplementation to Improve Mood in Healthy Adults Ages 21 to 65

Led by Kirin Holdings Company, Limited · Updated on 2025-09-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of citicoline on mood in healthy adults aged 21 to 65. This randomized, double-blind, placebo-controlled trial aims to compare mood changes between those taking citicoline and those receiving a placebo, with the goal of understanding how citicoline may influence mood in people without major health issues. The study involves a 4-week treatment period during which participants will be randomly assigned to receive either oral citicoline or a matching placebo. The trial is designed to keep both participants and researchers unaware of which treatment is given, ensuring unbiased results. Participants will maintain their usual diet, physical activity, and caffeine intake throughout the study. During the trial, participants will undergo cognitive assessments and complete questionnaires to measure mood, sleep quality, and stress levels. Blood samples will be collected to analyze brain-related biomarkers. The main outcome is the Total Mood Disturbance score after 4 weeks. Safety and adherence will be monitored, and the entire study duration for each participant is approximately one month.

CONDITIONS

Brief Title

Evaluate the Effects of Citicoline on Mood in Healthy Adults

Who Can Participate

Age: 21Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Provide voluntary signed and dated informed consent.
Be in good health as confirmed by medical history and routine blood tests.
Be a biological man or woman between 21 and 65 years old.
Have a Body Mass Index between 18.5 and 32.0.
Weigh at least 110 pounds.
Experience moderate mood disturbance during screening.
Have normal blood pressure (systolic <140 mm Hg and diastolic <90 mm Hg) when seated and resting.
Have a resting heart rate below 90 beats per minute.
Agree to maintain current diet and physical activity during the study.
Maintain usual caffeine intake not exceeding 400 mg per day.
If using dietary supplements started within the past month, be willing to stop them and complete a 2-week washout before participation.
Willing to duplicate previous 24-hour diet, refrain from caffeine, alcohol, and exercise for 24 hours before each visit, and fast for 10 hours before visits.

You will not qualify if you...

Quick Inventory of Depressive Symptomology (QIDS) score above 16.
Women who are pregnant, breastfeeding, or planning pregnancy during the trial; must have a negative pregnancy test at screening.
Women with Premenstrual Symptoms Screening Tool (PSST) score of 30 or higher.
Current smokers or those who quit within 3 months before screening.
Excessive alcohol use (more than 2 drinks per day or 10 drinks per week) or drug abuse.
Current use of nootropic supplements or medications that could affect study results.
History of liver, kidney, muscle, autoimmune, neurological, digestive, cardiovascular, metabolic, or inflammatory diseases.
Diagnosed cognitive or psychiatric disorders, or brain-related medical conditions.
Current use of medications for anxiety or depression.
Irregular or insufficient sleep patterns (less than 6 hours per night).
Known allergies or sensitivities to any study product ingredients.
Recent significant illness within 30 days.
Cognitive impairment or inability to provide informed consent.
Any other conditions that may affect study results or participant safety as judged by the investigator.

Research Team

Tim Ziegenfuss, Ph.D., CSCS, FISSN

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Study of Oral Citicoline Supplementation to Improve Mood in Healthy Adults Ages 21 to 65

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria