Dynamic Monitoring of Urinary Electrolytes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis
研究概览
简要总结
This interventional device feasibility study evaluates the operational feasibility of a prototype urinary electrolyte monitoring device in healthy adults aged 18 to 60 years. Urine samples will be collected during protocol-defined dietary intervention conditions and free-living conditions to determine whether the prototype device can generate complete urinary sodium, chloride, potassium, magnesium, and calcium measurement results without device malfunction, sample-processing failure, unreadable signal output, or repeat device operation.
Dietary intervention conditions are used to provide physiologic variation in urinary electrolyte levels and to create testing conditions for the prototype device. The primary outcome is the valid measurement rate of the prototype device across collected urine samples. Secondary outcomes will summarize changes in urinary electrolyte levels following dietary interventions and within-participant variability under free-living conditions.
Participants will provide baseline anthropometric and physiological data, including height, weight, age, and blood pressure, along with baseline fasting morning urine samples. Participants will consume assigned standardized meals or provide urine samples under free-living conditions, depending on study arm assignment. Longitudinal urine samples will be collected at protocol-defined time points, such as post-prandial intervals or other scheduled collection times during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Investigator)
盲法说明
The anticipated 40 participates are allocated to 5 parellel arms to verify the feasibility of device for testing 5 different urinary electrolytes to ensure 5-8 participates in each arms.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 18- and 60-year-old
- •Willing to join and complete the study
排除标准
- •Medical conditions, such as liver, kidney, gastrointestinal, or systemic diseases;
- •Drug taking or use within two weeks;
- •Pregnant women;
- •Lack of access to a smartphone
结局指标
主要结局
Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis
时间窗: Up to 2 weeks after study arm assignment.
Percentage of all collected urine samples for which the prototype device produces a complete urinary sodium, chloride, potassium, magnesium, and calcium measurement result without device malfunction, sample-processing failure, unreadable signal output, or need for repeat device operation. A valid measurement rate of 80% or higher will be considered to meet the protocol-defined feasibility criterion.
次要结局
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the high-fruit dietary intervention(Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the high-fruit dietary intervention.)
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the high-nut dietary intervention(Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the high-nut dietary intervention.)
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the calcium supplementation dietary intervention(Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the calcium supplementation dietary intervention.)
- Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the DASH dietary intervention(Baseline and daily for up to 2 weeks during the DASH dietary intervention.)
- Within-participant variability in urinary sodium, chloride, potassium, magnesium, and calcium levels under free-living conditions(Daily for up to 1 week under free-living conditions.)
研究者
Haisong Lin
Assistant Professor
Westlake University