Evaluate the Effects of Citicoline on Mood in Healthy Adults

NCT07089238 | Recruiting

• 1 other identifier: KIRIN-01-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cognitive; Citicoline; Cognitive performance; Mood

Outcome Measures

Primary Outcomes (1)

• Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2)

  To evaluate the effect of the Test Product (TP) on TMD on the POMS2 compared to a placebo

  4 weeks

Secondary Outcomes (4)

• Pittsburgh Sleep Quality Index (PSQI)

  4 weeks

• Perceived Stress Scale (PSS-10)

  4 weeks

• Serum Brain-Derived Neurotrophic Factor (BDNF) and Homovanilic Acid (HVA)

  4 weeks

• Profile of Mood States second eddition-Adult short (POMS2) subdomain scores

  4 weeks

Other Outcomes (1)

• Adverse events

  0-4 weeks

Study Arms (2)

Citicoline

ACTIVE COMPARATOR

Dietary Supplement: Citicoline

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Citicoline DIETARY_SUPPLEMENT

Oral

Citicoline

Placebo DIETARY_SUPPLEMENT

Oral

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirin Holdings Company, Limited: lead
• The Center for Applied Health Sciences: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

RECRUITING

MeSH Terms

Interventions

Cytidine Diphosphate Choline

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

Tim Ziegenfuss, Ph.D., CSCS, FISSN

CONTACT

519-341-3367; tz@appliedhealthsciences.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo will match the TP in physical and visual appearance and packaging and each participant's study product assignments will be associated with a unique code to prevent premature unblinding. Planned unblinding will occur following database lock, definition of study populations, and a blinded statistical analysis. Delegated unblinded site personnel will be responsible for study product accountability, reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposition records) throughout the course of the study. The investigator will have oversight in a blinded manner.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are 2 study groups, including one test product (TP) group and one placebo (PL) group. Healthy adult males and females who are 21 to 65 years of age (inclusive) at screening will be enrolled.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 28, 2025
• Study Start: July 31, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)