CTRI/2019/11/022146已完成不适用
Safety of a Food and Supplement-Based Detoxification Program in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.To compare the before and after CLEAN, metabolic detoxification score, among volunteers, without serious comorbid illness
研究概览
简要总结
This proposed study is a prospective, cohort, non-randomized single arm, pre- and post intervention study in healthy volunteers aged 21 to 65 Years. The primary endpoint is to establish the safety of a food and supplement based detoxification program among healthy subjects using the Metabolic Detoxification Questionnaire (MDQ). The total number of visits include 21 days of detoxification and four weeks of washout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age above 21 years and below 65 years 2.Either gender 3.Literate Subjects (with English speaking skills) who are willing to consent for 21day program under supervision (telephonic and Social Network), self-motivated to complete the program.
排除标准
- •1.Know history of food allergies or positive for IgG for 22 known food allergens.
- •2.Women in child bearing age, married or potential to be pregnant, refusing to perform a pregnancy confirmation test to rule out pregnancy.
- •3.Women breast feeding or within 6 months post-partum.
- •4.Use of prescription and non-prescription medication and/or nutritional supplements/medical foods for the support of detoxification in the past 3 months or taking regular medication for diabetes, hypertension or dyslipidaemia and not showing adequate control as per standard guidelines or likely to have changes in their prescription during the 21 day program.
- •5.Anyone to have changed their physical activity significantly 2 weeks before the study and throughout the duration of the study.
- •6.Active disease undergoing intensive or continuation therapy for any illness.
- •7.Unlikely to be able to stay compliant to the program for reasons discussed with the clinician.
结局指标
主要结局
1.To compare the before and after CLEAN, metabolic detoxification score, among volunteers, without serious comorbid illness
时间窗: Baseline, Visit 2 (Day 1), Visit 3 (Day 8) & Visit 4 (Day 15), Visit 5 (Day 22), and Visit 6 (Day 52)
次要结局
- 1.To compare the changes in baseline inflammatory screening panel, before and after CLEAN(2.To record incidence of any side effects to the CLEAN program)
研究者
研究点 (1)
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