NCT05000190已完成不适用
Acute and Chronic Effect of 250 mg Citicoline Consumption on Attention in Adults: A Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Errors of commission after 28-day consumption (chronic effect)
研究概览
简要总结
The primary study objectives are to test whether among a sample of healthy adults consuming: (1) a single capsule containing 250 mg citicoline has an effect on attentional performance 1, 2 and 3 h post-dose compared to placebo (acute effect), and (2) capsule containing 250 mg citicoline per day for 28 consecutive days has an effect on attentional performance compared to placebo (chronic effect).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating females, 18-60 years of age
- •Self-report of good health
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
- •Willing to maintain current dietary supplement use (e.g., multi-vitamin or other supplements approved by investigator, stimulants excluded) throughout the 28 days of the trial. On test days, participant agrees not to take any of their usual dietary supplements until dismissal from University of Georgia.
- •Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
- •Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
排除标准
- •Failure to meet any one of the inclusion criteria
- •Potential participant will be excluded if the individual is being paid to do work by Dr. O'Connor, is unwilling to comply with safety instructions (e.g., to wear a face covering) or reports:
- •Vision problems that cannot be corrected with glasses or contact lenses
- •usual daily consumption of ≥ 500 mg caffeine
- •Consumption of caffeine or other stimulants, such as stimulant medication commonly used for ADHD (e.g. Ritalin or Adderall), within 12 h of testing. Prescription medications are allowed as long as they do not interfere with testing.
- •Major trauma or major surgical event within 6 months of screening
- •Known intolerance, sensitivity or allergy to any ingredients in the study products
- •Extreme dietary habits, as judged by the Investigator
- •Moderate or higher intensity exercise of 15 or more minutes completed fewer than 3-h prior to a laboratory testing session.
- •Consumption of food or caloric drinks fewer than 2-h prior to the laboratory testing session.
- •Consumption of supplements, vitamins and multi-vitamins prior to testing on testing days. Participants can take dietary supplements that they have agreed to maintain on testing days after completing the testing visit.
- •Any history of a diagnosed psychiatric or neurobehavioral (e.g., ADHD) disorder
- •A history of frequent gastrointestinal distress in response to meals or medicine
- •History of cancer in the prior two years, except for non-melanoma skin cancer
- •Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
- •Exposure to citicoline within 30 d prior to screening
- •Participant has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
- •Increased risk of exposure to COVID-19
- •Increased risk of a severe reaction to exposure to COVID-19
- •Participation in a PepsiCo study at the University of Georgia for at least 6 months from signing the consent form
- •Participation in any clinical trial for at least 30 days from signing the consent form
结局指标
主要结局
Errors of commission after 28-day consumption (chronic effect)
时间窗: Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores
Attention performance during the Connors Continuous Performance Test- version III (CPT-III)
次要结局
- Errors of commission after acute dosing (single dose on Day 1, the first of 28 daily doses)(Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1))
- Errors of omission after acute dosing(Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1))
- Reaction time after acute dosing(Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose (baseline Day 1))
- For the acute study only, expectation for change in mental task performance associated with consuming one capsule that may contain citicoline(Immediately post-dose (baseline Day 1))
- For acute study only, sleep behavior the night prior to testing(Upon arrival (baseline Day 1))
- For the acute study only, motivation to complete the attention task(Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose immediately prior to tests of attention)
- Errors of omission after chronic dosing(Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores)
- Reaction time after chronic dosing(Post treatment Day 29 minus pre-treatment (baseline Day 1) change scores)
- For the chronic study only, high frequency (HF) and low frequency (LF) domains of heart rate variability, a biomarker of cognitive function, during the tests of attention(Change from pre-dose baseline Day 1 to Day 29)
- For the acute study only, mood states (anxiety)(Immediately prior to the test of attention, change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose mood states, immediately prior to tests of attention)
- For the acute study only, high frequency (HF) and low frequency (LF) domains of heart rate variability, a biomarker of cognitive function, during the tests of attention(Change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose)
- For the chronic study only, motivation to complete the attention task(Change from pre-dose baseline Day 1 to Day 29)
- For the chronic study only, feelings of mental energy and fatigue(Immediately prior to test of attention, change from pre-dose baseline Day 1 to Day 29)
- For the chronic study only, mood states (anxiety) questionnaire(Immediately prior to test of attention, change from pre-dose baseline Day 1 to Day 29)
- For the acute study only, feelings of mental energy and fatigue(Immediately prior to the test of attention, change from pre-dose baseline to 1 hour, 2 hours and 3 hours post dose)
- For the chronic study only, expectation for change in mental task performance associated with consuming one capsule daily for 28-days that may contain citicoline(Change from post-dose baseline Day 1 to Day 29 measured by)
- For the chronic study only, sleep behavior the night prior to testing(Change from number of hours of sleep the night before baseline Day 1 versus the number of hours of sleep the night before Day 29)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in GlaucomaGlaucomaNeuroprotectionNCT06431113Fondazione IRCCS Policlinico San Matteo di Pavia40
已完成
不适用
Citicoline Concentration in Human VitreousNeurodegenerative DiseasesNCT04003090Istituto di Ricerca Neuroftalmologia S.r.l.26
终止
不适用
Effect of Citicoline/Homotaurine on PERG in Primary Open Angle GlaucomaGlaucomaNCT04422743Fondazione IRCCS Policlinico San Matteo di Pavia63
已完成
3 期
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/DependenceHypomaniaCocaine AbuseCocaine DependenceManiaNCT00223236University of Texas Southwestern Medical Center44
进行中（未招募）
2 期
Citicoline in Youth Alcohol Use DisorderAlcohol Use DisorderNCT05870111Medical University of South Carolina56