NCT04130724已完成不适用
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status and Comparison to Blood Ketone Testing
Readout, Inc.1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations
研究概览
简要总结
The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Ketogenic diet cohort: currently following a ketogenic or low-carbohydrate diet defined as less than 30 grams per day (ketogenic) or less than 100 grams per day (low-carbohydrate) as estimated by the individual. Subjects must have been following the diet before the beginning of the study period and must continue with the diet throughout the duration of the trial.
- •High-carbohydrate diet cohort: currently following a diet that does not restrict dietary carbohydrate. Carbohydrate consumption should be greater than 100 grams per day as estimated by the individual. Subjects must have been following the diet before the study period and must continue with the diet throughout the duration of the trial.
排除标准
- •Type-1 diabetes
- •Insulin-dependent type-2 diabetes
- •History of diabetic ketoacidosis
- •Currently taking Warfarin or other blood thinners
- •Currently taking a sodium-glucose cotransporter-2 (SGLT2) inhibitor
- •Currently taking Disulfiram
- •Unwilling to maintain their diet during the study period
- •Unwilling to test blood and breath ketones five times per day
- •Non-English speaking
- •Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
结局指标
主要结局
Correlation between breath acetone (BrAce) and blood beta-hydroxybutyrate (BHB) concentrations
时间窗: 2 weeks
Blood BHB and BrAce measurements will be taken simultaneously during at least five (5) measurement sessions each day. After aggregating data from all study participants, the correlation between these two measurements will be determined using regression analysis.
次要结局
- Reliability of the Readout breath acetone device(2 weeks)
研究者
研究点 (1)
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