Dynamic Monitoring of Urinary Electrolytes

Condition(s) studied

Investigational drug(s) / intervention(s)

Urinary electrolyte: Urine is collected and tested on the device.

fruit diet: Participants will consume assigned standardized meals including fruit.

nut diet: Participants will consume assigned standardized meals including nut.

calcium supplement diet: Participants will consume assigned standardized meals including calcium supplements.

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

Study 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.

Eligibility

Primary outcome measure(s)

• Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis — 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.

Trial sites (1)

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