Dynamic Monitoring of Urinary Electrolytes

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.

Conditions

• Healthy

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.

Sponsors & Collaborators

• Westlake University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-20

Primary Completion

2026-08-20

Completion

2026-09-30

Countries

• China

Study Locations