Citicoline effects on mood in healthy adults

Exploring the Effects of Citicoline Supplementation on Validated Subjective and Objective Markers of Mood in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial

This 4-week, randomized, double-blind trial will test whether daily citicoline helps improve mood in healthy adults compared with a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Kirin Holdings Company, Limited (Industry-sponsored)
• Locations: 1 site (Canfield, Ohio)
• Trial ID: NCT07089238 on ClinicalTrials.gov

What this trial studies

This is a 4-week, randomized, double-blind, placebo-controlled trial enrolling healthy men and women aged 21–65 who report moderate mood disturbance. Participants will be randomly assigned to daily citicoline or a matching placebo and will undergo routine bloodwork along with cognitive and mood assessments at baseline and follow-up visits. Outcomes will compare changes in mood and cognitive performance between the citicoline and placebo groups. The protocol requires participants to meet health, BMI, blood pressure, and supplement-use criteria and to attend all in-person visits at a single site in Canfield, Ohio.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 21–65 with moderate mood disturbance, a BMI of 18.5–32, normal blood pressure and heart rate, and willingness to stop certain supplements and attend in-person visits.

Not a fit: People with diagnosed major depressive disorder, unstable medical conditions, significant cardiovascular issues, or those unable to attend onsite visits are unlikely to be eligible or to gain benefit from this protocol.

Why it matters

Potential benefit: If successful, citicoline could offer a well-tolerated, easily accessible option to modestly improve mood and related cognitive function in otherwise healthy adults.

How similar studies have performed: Prior small studies and clinical reports suggest citicoline can provide modest cognitive and mood benefits, but the overall evidence is limited and mixed.

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.

Where this trial is running

Canfield, Ohio

• The Center for Applied Health Sciences — Canfield, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Tim Ziegenfuss, Ph.D., CSCS, FISSN

Conditions Healthy; Cognitive; Citicoline; Cognitive performance; Mood