The Effect of Onnit New Mood Supplementation in Healthy Collegiate Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in resting heart rate (beats per minute) over 8 weeks
研究概览
简要总结
The primary purpose of this study is to assess the effectiveness of ONNIT Lab's New Mood™ dietary supplement in supporting optimal mood balance and reducing daily stress among collegiate-aged men and women. To be considered for this study, the participant must meet the following criteria: (1) current undergraduate student at the University of Idaho between 18-24 years of age, (2) have no known allergies to the ingredients of New Mood™ (Niacin, Vitamin B6, Magnesium, Valerian Extract, Lemon Balm Extract, L-Tryptophan. 5-Hydroxytryptophan, and Inositol) or the placebo (rice bran and maltodextrin), (3) not currently taking any mood/sleep supplementation or medications, (4) not currently seeking therapy or diagnosed with a psychological disorder, (5) not regularly using cigarettes, marijuana, or other illicit drugs, and (6) not pregnant or breastfeeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently enrolled collegiate men and women at the University of Idaho
排除标准
- •Currently taking mood or sleep enhancing supplementation/medication
- •Currently participating in counseling and/or therapy sessions
- •Previously diagnosed with a psychological disorder
结局指标
主要结局
Change in resting heart rate (beats per minute) over 8 weeks
时间窗: Change from baseline resting heart rate (beats per minute) response at 8 weeks
Manual radial pulse measurement of resting heart rate (beats per minute) at baseline and 8 weeks
Change in resting systolic and diastolic blood pressure (mm Hg) over 8 weeks
时间窗: Change from baseline resting systolic and diastolic blood pressure (mm Hg) at 8 weeks
Digital sphygmomanometer measurement of resting systolic and diastolic blood pressure (mm Hg) at baseline and 8 weeks
Change in depression, anxiety and stress scores (0-34) over 8 weeks
时间窗: Change from baseline DASS-21 score at 8 weeks
Depression, Anxiety and Stress Scale Questionnaire (DASS-21, 0-34) to assess depression, anxiety and stress scores from baseline to 8 weeks
Change in cortisol awakening response (mg/dL) over 8 weeks
时间窗: Change from baseline cortisol awakening response (mg/dL) at 8 weeks
Three salivary cortisol measurements to determine cortisol awakening response (mg/dL) from baseline to 8 weeks
次要结局
未报告次要终点
研究者
Ann Brown
Assistant Professor
University of Idaho