Dynamic Monitoring of Urinary Electrolytes

NCT07704450 | Not Yet Recruiting

• 2 other identifiers: 20260114LHS00120260521LHS001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis

  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.

  Up to 2 weeks after study arm assignment.

Secondary Outcomes (5)

• 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.

Study Arms (5)

fruit diet (for potassium intake)

EXPERIMENTAL

Device: Urinary electrolyte; Dietary Supplement: fruit diet

nut diet (for magnesium intake)

EXPERIMENTAL

Device: Urinary electrolyte; Dietary Supplement: nut diet

Calcium supplement diet (for calcium intake)

EXPERIMENTAL

Device: Urinary electrolyte; Dietary Supplement: calcium supplement diet

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

EXPERIMENTAL

Device: Urinary electrolyte; Dietary Supplement: DASH diet

Uncontrol

EXPERIMENTAL

Device: Urinary electrolyte

Interventions

Urinary electrolyte DEVICE

Urine is collected and tested on the device.

Calcium supplement diet (for calcium intake); DASH Diet (for low-salt and high-fruit intake); Uncontrol; fruit diet (for potassium intake); nut diet (for magnesium intake)

fruit diet DIETARY_SUPPLEMENT

Participants will consume assigned standardized meals including fruit.

fruit diet (for potassium intake)

nut diet DIETARY_SUPPLEMENT

Participants will consume assigned standardized meals including nut.

nut diet (for magnesium intake)

calcium supplement diet DIETARY_SUPPLEMENT

Participants will consume assigned standardized meals including calcium supplements.

Calcium supplement diet (for calcium intake)

DASH diet DIETARY_SUPPLEMENT

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Westlake University: lead

Study Sites (1)

Westlake University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Dietary Approaches To Stop Hypertension

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Haisong LIN

CONTACT

+86 18503060398; linhaisong@westlake.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 15, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)