NCT04556032终止不适用
A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
Midwest Center for Metabolic and Cardiovascular Research2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2020年9月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
研究概览
简要总结
The objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women.
详细描述
This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of one screening (visit 1a, week 0), one baseline visit (visit 1b, week 0), and three treatment visits (visits 2, 3, and 4; weeks 4, 8, and 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 55-79 years of age.
- •Body mass index (BMI) 18.50-34.99 kg/m2
- •Non-smoker defined as no smoking for at least 6 months.
- •Willing to limit alcohol and caffeine consumption
- •Generally, in good health based on medical history and laboratory assessments
- •Agree to avoid consumption of mushrooms and excluded medications/supplements for the duration of the study
- •Willing to commit to all study procedures
排除标准
- •Consumption of mushrooms more than once per week
- •History or presence of a psychiatric or neurologic disease including, but not limited to, epilepsy, cerebrovascular disturbance, traumatic injury, or clinically diagnosed dementia or Alzheimer's disease.
- •Scores ≥17 on the Beck Depression Inventory
- •History of cardiovascular complications, type 1 or type 2 diabetes mellitus, uncontrolled hypertension, or any other clinically significant disorder
- •History of cancer except non-melanoma skin cancer or carcinoma in situ of the cervix within the past 2 years
- •Use of any product containing marijuana (THC) and/or cannabidiol (CBD) including oral consumption, inhalation, & other
- •Any intolerance to any components of the study products
- •Exposure to any non-registered drug product within the past 30 days
- •History of drug or alcohol abuse
- •Considered unfit for any reason as determined by the principal investigator
结局指标
主要结局
Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
时间窗: Baseline to Week 16
次要结局
- Changes in mood based on Profile of Mood States Questionnaire (POMS)(Baseline to weeks 4, 8 and 16)
- Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery(Baseline to weeks 4 and 8)
- Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)(Baseline to weeks 4, 8 and 16)
- Changes in standard scores for domains relating to memory, attention, and executive function from the Central Nervous System Vital Signs (CNS-VS) Test Battery(Baseline to weeks 4, 8 and 16)
研究者
研究点 (2)
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