HealthyNCT07089238
Evaluate the Effects of Citicoline on Mood in Healthy Adults
A study testing Citicoline in people with Healthy, run by Kirin Holdings Company, Limited at 1 site in United States.
Trial summary
The objective of this trial is to determine the effects of citicoline on mood in healthy Men and Women compared to a placebo. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Citicoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for Applied Health Sciences
Canfield, Ohio, 44406
Tim Ziegenfuss, Ph.D., CSCS, FISSN, 519-341-3367, tz@appliedhealthsciences.org
About this study
Official title: 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
The objective of this trial is to determine the effects of citicoline on mood in healthy Men and Women compared to a placebo.
Read the 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
- Being tested
- Citicoline, Placebo
- Keywords
- Cognitive, Citicoline, Cognitive performance, Mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiticolineDietary supplement
Oral
PlaceboDietary supplement
Oral
| Study group | Role | What they receive |
|---|---|---|
| Citicoline | Active comparator | Not described Receives: Dietary Supplement: Citicoline |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
Pittsburgh Sleep Quality Index (PSQI)
To evaluate the effect of the TP on PSQI compared to a placebo
Measured: 4 weeks
Perceived Stress Scale (PSS-10)
To evaluate the effect of the TP on PSS-10 compared to a placebo
Measured: 4 weeks
Serum Brain-Derived Neurotrophic Factor (BDNF) and Homovanilic Acid (HVA)
To evaluate the effect of the TP on serum BDNF and HVA compared to a placebo
Measured: 4 weeks
Profile of Mood States second eddition-Adult short (POMS2) subdomain scores
To evaluate the effect of the TP on POMS2 subdomain scores compared to a placebo
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start31 Jul 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirin Holdings Company, Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089238
- Sponsor's protocol ID
- KIRIN-01-2025
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07089238
- Acronym / sponsor ID
- KIRIN-01-2025
- Conditions
- Healthy
- Keywords
- Cognitive, Citicoline, Cognitive performance, Mood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kirin Holdings Company, LimitedIndustry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Citicoline | Active comparator | Dietary Supplement: Citicoline |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiticolineOral | Dietary supplement | Citicoline |
| PlaceboOral | Dietary supplement | Placebo |
Primary outcome
Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2)
Time frame: 4 weeks
To evaluate the effect of the Test Product (TP) on TMD on the POMS2 compared to a placebo
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
Perceived Stress Scale (PSS-10)
Time frame: 4 weeks
Serum Brain-Derived Neurotrophic Factor (BDNF) and Homovanilic Acid (HVA)
Time frame: 4 weeks
Profile of Mood States second eddition-Adult short (POMS2) subdomain scores
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline in people with Healthy, run by Kirin Holdings Company, Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Ziegenfuss, Ph.D., CSCS, FISSN (519-341-3367, tz@appliedhealthsciences.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.