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ACTIVE NOT RECRUITING
NCT07704450
NA

Dynamic Monitoring of Urinary Electrolytes

Sponsor: Westlake University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07-20

Completion Date

2026-09-30

Last Updated

2026-08-27

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Urinary electrolyte

Urine is collected and tested on the device.

DIETARY_SUPPLEMENT

fruit diet

Participants will consume assigned standardized meals including fruit.

DIETARY_SUPPLEMENT

nut diet

Participants will consume assigned standardized meals including nut.

DIETARY_SUPPLEMENT

calcium supplement diet

Participants will consume assigned standardized meals including calcium supplements.

DIETARY_SUPPLEMENT

DASH diet

Participants will consume assigned low salt high fruit meals following DASH diet guidance.

Locations (1)

Westlake University

Hangzhou, Zhejiang, China