Study to Evaluate the Efficacy of Bare Performance Nutrition's Peak Sleep Supplementation on Sleep Quality and Duration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in sleep quality
研究概览
简要总结
This is a single-blinded observational randomized-control trial to study the efficacy of a dietary supplement and its effect on sleep quality, recovery, and workout performance.
详细描述
This is a single-blinded observational randomized-control trial to study the efficacy of a dietary supplement and its effect on sleep quality, recovery, and workout performance.
It is hypothesized that the dietary supplement "Peak Sleep" will improve sleep quality - as defined as deep sleep, REM sleep, and feeling more rested the next day, as well as promoting the performance in workouts of trial participants.
A total of 72 participants will be recruited for the trial following the screening. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants, and participants will either receive the "Peak Sleep" product or receive a placebo - depending on the study group they got randomized in - for eight weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 24 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male & Female between 24-45 years old
- •Self-reported mild to moderate sleep issues
- •3+ days of physical exercise per week
- •Self-reported stressful lifestyle
- •Own a sleep tracker that can be used for the study (e.g. Oura ring, Apple Watch, FitBit, -Whoop band, or similar other devices)
- •Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- •Following a stable, consistent diet regimen
- •Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes
排除标准
- •Severe chronic conditions including oncological conditions, psychiatric disease, or other
- •Diagnosed insomnia
- •Food intolerances/allergies that require an EpiPen
- •Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
- •Individuals that participate in another research study during the study period
- •Individuals with a history of drug, alcohol, or substance abuse
- •Individuals taking any other sleep supplements and are unwilling to stop taking those supplements for the duration of the study period
- •Individuals who have night terrors regularly
- •Individuals who regularly sleepwalk
- •Individuals who have regular bad dreams
结局指标
主要结局
Change in sleep quality
时间窗: Baseline to 8 weeks
Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in sleep quality between baseline and study intervention period.
Change in recovery time after a workout
时间窗: Baseline to 8 weeks
Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in workout recovery time between baseline and study intervention period.
次要结局
未报告次要终点