Healthy
Conditions
Keywords
Cognitive, Citicoline, Cognitive performance, Mood
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.
Interventions
DIETARY_SUPPLEMENTCiticoline
Oral
DIETARY_SUPPLEMENTPlacebo
Oral
Sponsors
The Center for Applied Health Sciences
Kirin Holdings Company, Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2) | 4 weeks | To evaluate the effect of the Test Product (TP) on TMD on the POMS2 compared to a placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | 4 weeks | To evaluate the effect of the TP on PSQI compared to a placebo |
| Perceived Stress Scale (PSS-10) | 4 weeks | To evaluate the effect of the TP on PSS-10 compared to a placebo |
| Serum Brain-Derived Neurotrophic Factor (BDNF) and Homovanilic Acid (HVA) | 4 weeks | To evaluate the effect of the TP on serum BDNF and HVA compared to a placebo |
| Profile of Mood States second eddition-Adult short (POMS2) subdomain scores | 4 weeks | To evaluate the effect of the TP on POMS2 subdomain scores compared to a placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 0-4 weeks | To assess the safety and tolerability of the TP in healthy participants: Reports of Adverse Events to determine number of participants with adverse events. |
Countries
United States
Contacts
Primary ContactTim Ziegenfuss, Ph.D., CSCS, FISSN
Outcome results
None listed