NCT04985630招募中不适用
Open-labelled Study to Validate Home-based Use of a Health and Wellness Kit (The Mitopure Challenge) to Detect Levels of Urolithin A in Dried Blood Spots After Intake of Mitopure (Proprietary Urolithin A)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amazentis SA
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Failure/rejection rate (% of the samples) collected at home by participants.
研究概览
简要总结
Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18 to 80 years of age;
- •Is in general good health, as determined by the research team;
- •Willingness to consume the investigation product, complete questionnaires and to complete the study;
- •Have given voluntary, electronic, informed consent to be a participant in the study.
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- •Volunteers who plan to donate blood during the study or within 30 days of completing the study;
- •Subject has a known allergy to the test material's active or inactive ingredients;
- •Subjects with unstable medical conditions;
- •Participation in a clinical research trial within 30 days prior to randomization;
- •Allergy or sensitivity to study ingredients;
- •Individuals who are cognitively impaired and/or who are unable to give informed consent;
- •Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject;
- •Has taken antibiotics within the previous 30 days.
结局指标
主要结局
Failure/rejection rate (% of the samples) collected at home by participants.
时间窗: 4 weeks
Acceptability target goal is to hit 80% of analyzed samples
次要结局
- Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.(4 weeks)
- Fold change increase in the levels of UA-Glucuronide (in ng/mL) in the dried blood spots provided in the kit before and after the challenge(4 weeks)
- Validation of a health questionnaire on participants health status(4 weeks)
研究者
研究点 (2)
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