NCT07089238招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2)
研究概览
简要总结
The objective of this trial is to determine the effects of citicoline on mood in healthy Men and Women compared to a placebo.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •QIDS (Quick Inventory of Depressive Symptomology) score >
- •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.
研究组 & 干预措施
Citicoline
Active Comparator
干预措施: Citicoline (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Total Mood Disturbance (TMD) score on the Profile of Mood States second eddition-Adult short (POMS2)
时间窗: 4 weeks
To evaluate the effect of the Test Product (TP) on TMD on the POMS2 compared to a placebo
次要结局
- 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)
研究者
研究点 (1)
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