Study to Evaluate the Efficacy of Asystems' Complete Calm Supplementation on Sleep Quality and Duration, Anxiety, and Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in stress and anxiety [Time Frame: Baseline to 4 weeks)
研究概览
简要总结
This is an open-label observational single-arm clinical trial to study the efficacy of a commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood, and stress.
详细描述
It is hypothesized that the dietary supplement marketed as "Asystems Complete Calm" (consisting of De-Stress Gummies and Sleep Gummies) will improve subjective wellbeing in trial participants, through promoting restful sleep (looking at sleep quality and duration), and reducing stress and anxiety, while lifting up the participants' mood.
A total of 35 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 all participants will take the Complete Calm Product, consisting of the De-Stress Gummies (day) and Sleep Gummies (night) for four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 (undiagnosed) mild to moderate sleep issues
- •Self-reported (undiagnosed) mild to moderate anxiety
- •Self-reported stressful lifestyle
- •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
- •Currently taking any prescription anti-depressants
- •Currently receiving other psychotherapeutic treatment for anxiety or depression
- •Severe chronic conditions including oncological conditions, psychiatric disease, or other
- •Diagnosed insomnia
- •Diagnosed anxiety or depression
- •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
结局指标
主要结局
Change in stress and anxiety [Time Frame: Baseline to 4 weeks)
时间窗: 4 weeks
Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in stress/anxiety between baseline and study intervention period.
Change in sleep quality [Time Frame: Baseline to 4 weeks)
时间窗: 4 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.
次要结局
未报告次要终点