Functional Assessment of Ashwagandaha Root Extract During Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale PSS
研究概览
简要总结
Patients who are involved in a clinical protocol driven 12 week medical weight loss intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root extract. The study endpoints are primarily the patients self-reported perception of life stress and sleep quality. The working hypothesis of this study is that the addition of aschwagandha to .the medical weight loss program will improve the self-reported perception of life stress and sleep quality
详细描述
During this 12-week medical weight loss program, the randomized patients will also have a baseline measurements and final measurements of blood for selected adipokines , cytokines, and telomerase measurements
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •BMI of 27 kg/m2 with comorbidities or 30 kg/m2 and above
- •Perceived Stress Scale (PSS) score of ≥ 20 at screening
- •Age 18 to 70 years
- •Generally healthy male or female in the judgement of the principal investigator.
- •Able to attend the testing site at CHP.
- •Access to a computer and are able to enter information into the computer
排除标准
- •Exclusion criteria (Justification of exclusion group based on demographics or their vulnerability)
- •Taking chronic anti-anxiety, anti-obesity (other than phentermine) or anti-insomnia medication on a regular basis and unwilling to stop taking these classes of medications for the duration of the 12 week trial.
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Nursing an infant
- •Currently undergoing cancer treatment
- •Untreated hypertension, diabetes or cardiac arrhythmias
- •Dieting to lose weight in the last month
- •Started within the last 14 days or plan to start taking:
- •Birth control pills
- •Hormone supplements (Estrogen/Progesterone etc)
- •MAO inhibitors, Oral Corticosteroids, Tricyclic antidepressants, SSRI's (except Fluoxetine),
结局指标
主要结局
Perceived Stress Scale PSS
时间窗: 12 weeks
Standardized questionnaire
次要结局
- Pittsburgh Sleep Quality Index PSQI(12 weeks)
- Food Craving Questionnaire - Trait FCQ-T(12 weeks)
- Three-Factor Eating Questionnaire TFEQ(12 weeks)