Evaluate the Effects of Citicoline on Mood in Healthy Adults

NCT ID: NCT07089238

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-03-31

Brief Summary

The objective of this trial is to determine the effects of citicoline on mood in healthy Men and Women compared to a placebo.

Detailed Description

This study is a 4-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women. Cognitive assessments will be performed to determine whether citicoline administration improves mood, compared to placebo administration.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Citicoline

Group Type: ACTIVE_COMPARATOR

Citicoline

Intervention Type: DIETARY_SUPPLEMENT

Oral

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral

Interventions

Citicoline

Oral

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Provide voluntary signed and dated informed consent.
• Be in good health and able to participate as determined by medical history and routine blood chemistries.
• Biological men and women between 21 and 65 years of age (inclusive).
• Body Mass Index of 18.5-32.0 (inclusive).
• Body weight of at least 110 pounds.
• Participant is experiencing moderate levels of mood disturbance during screening.
• Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg.
• Normal supine, resting heart rate (<90 per minute).
• Agrees to maintain their existing dietary and physical activity patterns throughout the study period.
• Participants agree to maintain their usual caffeine consumption habits, given that they do not exceed the maximum intake per day (400mg/day or 3-4 cups of coffee per day).
• If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
• Willing to duplicate their previous 24-hour diet, refrain from caffeine for 24 hours, refrain from alcohol and exercise for 24 hours prior to each trial, and fast for 10 hours prior to each visit.

Exclusion Criteria

• QIDS (Quick Inventory of Depressive Symptomology) score > 16.
• Women who are pregnant, lactating, or planning to become pregnant during the study. Women must have a negative pregnancy test at screening.
• Women with a PSST (Premenstrual Symptoms Screening Tool) score ≥30
• Current smokers or cessation within 3 months prior to screening.
• Alcohol consumption (>2 standard alcoholic drinks/day or >10 drinks/week) or drug abuse/dependence.
• Current use of any nootropic dietary supplements (e.g., GABA, Ashwaghanda, St. John's Wort, Ginkgo biloba, L-theanine, choline, Lion's mane, creatine, etc.) or medications (e.g., piracetam, Adderall, modafinil, etc.) that may confound the study or its endpoints.
• Medical history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
• Individuals who have been diagnosed with digestive, liver, renal, cardiovascular, or other metabolic diseases.
• Other known gastrointestinal or metabolic diseases that might impact nutrient absorption, distribution, metabolism, or excretion (e.g., intestinal malabsorption, electrolyte abnormalities, diabetes, thyroid disease, adrenal disease, hypogonadism, short bowel syndrome, diarrheal illnesses, history of colon resection, gastric ulcer, reflux disease, gastroparesis, Inborn-Errors-of-Metabolism, etc.).
• Chronic medically diagnosed inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Medical history of a cognitive (i.e., ADD/ADHD) or psychiatric disorder, or brain-related medical conditions (e.g., TBI, ADHD).
• Currently using medications to treat anxiety or depression.
• Have an irregular sleep pattern (i.e. shift workers) or inadequate sleep schedule (i.e., less than 6 hours per night).
• Known sensitivity, allergy, or intolerability to any ingredient in the test products.
• Participants who report a clinically significant illness within the last 30 days.
• Individuals who are cognitively impaired and/or who are unable to give informed consent.
• Any other diseases or conditions that, in the opinion of the Principal Investigator, could confound the primary endpoint or place the subject at increased risk of harm if they were to participate.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Center for Applied Health Sciences

UNKNOWN

Sponsor Role: collaborator

Kirin Holdings Company, Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Center for Applied Health Sciences

Canfield, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tim Ziegenfuss, Ph.D., CSCS, FISSN

Role: CONTACT

tz@appliedhealthsciences.org

519-341-3367

Facility Contacts

Tim Ziegenfuss, Ph.D., CSCS, FISSN

Role: primary

tz@appliedhealthsciences.org

519-341-3367

Other Identifiers

KIRIN-01-2025

Identifier Type: -

Identifier Source: org_study_id