NCT06935123尚未招募1 期
A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Evaluating Nutritional Supplementation On Sleep Quality
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 376
- 试验地点
- 2
- 主要终点
- PROMIS Sleep Disturbance 8A
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent.
- •Be between 18-65 years of age (inclusive).
- •Insomnia severity Index score ≤
- •PROMIS Sleep Disturbance Questionnaire raw score ≥23
- •Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- •Willing to consume the study product daily for the duration of the study.
排除标准
- •Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- •Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.
- •Has a history of drug and/or alcohol abuse.
- •Hypersensitive to the contents of the study product.
- •Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.
- •High caffeine intake, >400mg/day.
- •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:
- •Diagnosed Sleep disorders
- •Major psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression)
- •Immunocompromised health conditions
- •Currently or recently (in the past 4 weeks) taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- •Prescribed sleep medications
- •Prescribed Medications which impact sleep, including but not limited to sedative hypnotics, anxiolytics, and antidepressants.
- •Current or recent (in the past 4 weeks) use of prohibited nutritional and non-nutritional supplements with known or possible sleep effects (e.g. valerian, multivitamins, melatonin)
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
结局指标
主要结局
PROMIS Sleep Disturbance 8A
时间窗: 0, 4, 8, and 12 weeks
Perceived sleep quality
次要结局
- PROMIS Sleep Related Impairment 8A(0, 4, 8, and 12 weeks)
- Insomnia Severity Index (ISI)(0, 4, 8, and 12 weeks)
- Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)(0, 4, 8, and 12 weeks)
- Bristol Stool Scale (BSS)(0, 4, 8, and 12 weeks)
研究者
研究点 (2)
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