Dynamic Monitoring of Urinary Electrolytes

Westlake University

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: nut diet; Dietary Supplement: calcium supplement diet; Dietary Supplement: DASH diet; Device: Urinary electrolyte; Dietary Supplement: fruit diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07704450

20260521LHS001 (Other Identifier)

20260114LHS001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged between 18- and 60-year-old
• Willing to join and complete the study

Exclusion criteria

• 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

fruit diet (for potassium intake)

Experimental group

Treatment:

Dietary Supplement: fruit diet

Device: Urinary electrolyte

nut diet (for magnesium intake)

Experimental group

Treatment:

Device: Urinary electrolyte

Dietary Supplement: nut diet

Calcium supplement diet (for calcium intake)

Experimental group

Treatment:

Device: Urinary electrolyte

Dietary Supplement: calcium supplement diet

DASH Diet (for low-salt and high-fruit intake)

Experimental group

Treatment:

Device: Urinary electrolyte

Dietary Supplement: DASH diet

Uncontrol

Experimental group

Treatment:

Device: Urinary electrolyte