The Impact of Ashwagandha on Stress, Sleep and Food Cravings in College Students: A Mixed Method Double-blinded Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Impact of ashwagandha on Perceived Stress
研究概览
简要总结
The purpose of this study was to compare the impact of 700 mg daily ashwagandha (Withania Somnifera) in healthy college students on sleep, stress and food cravings to healthy college students taking placebo.
详细描述
College aged students tend to report significant daily stress but there is no research on herbal interventions to ameliorate this condition in this population.
This study is a mixed methods, randomized, double blinded, placebo controlled 30 day trial targeting a college aged population. Participants are randomly allocated to either an intervention group (ashwagandha) or a placebo group. Each participant is given a bottle of capsules (capsules look identical but are filled either with a full spectrum dried extract ashwagandha herb or a placebo filled with glycerin). Directions included consuming 1 capsule in the morning and one capsule in the evening. Questionnaires were collected prior to the study and at the end of the study, including an assessment of daily affect. A subset of each group volunteered to attend an intervention specific focus group at 30 days completion of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The company (Gaia Herbs) prepared the intervention and placebo and had knowledge with Intervention A and B. Neither the investigators, coordinators, subjects or data analyst had knowledge of the group designation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Enrolled at the university
排除标准
- •sensitivity to nightshade vegetables;
- •peptic ulcer;
- •pregnant or expected to become pregnant in the near future;
- •breastfeeding;
- •had recent or planned surgery;
- •hypotensive;
- •diagnosed with diabetes;
- •and/or taking any of the following classes of medications: benzodiazepines, central nervous system depressants, diabetes medication, thyroid medication, immune suppressors, cardiovascular medication.
结局指标
主要结局
Impact of ashwagandha on Perceived Stress
时间窗: Change of perceived stress at 30 days
Stress was assessed using the Perceived Stress Scale a 10-item validated questionnaire measuring the degree to which situations in participant's life were viewed as stressful. Questions addressed anxious thoughts, locus of control, and coping mechanisms. Scores range from 0-40 (higher scores indicate higher stress levels).
Impact of ashwagandha on Food Cravings
时间窗: Change of food cravings at 30 days
Eating behavior was assessed using the Food Cravings Questionnaire, a 15-item validated instrument assessing food behavior and appetite using Likert-scales related to intentions for eating, perceived control, hunger cues, emotional states, and guilt associated with cravings. Scores range between 15 and 90 (higher scores indicate more frequent and intense food cravings).
Impact of ashwagandha on Sleep
时间窗: Change of restorative sleep quality at 30 days
Restorative Sleep Questionnaire is a 9-item validated scale assessing feelings and experiences about the participant's sleep and their perception of daytime consequences associated with their sleep patterns. Scores range from 0-100 where higher scores indicate better quality sleep.
次要结局
- Daily check in qualitative analysis(Up to 30 days)
- Qualitative analysis of ashwagandha on college students across sleep, stress and food cravings.(At 30 days)
研究者
Margaret Harris
Associate Professor
University of Colorado, Colorado Springs