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NCT Number: NCT07704450

Dynamic Monitoring of Urinary Electrolytes

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urinary electrolyte

Device

Urine is collected and tested on the device.

fruit diet

Dietary Supplement

Participants will consume assigned standardized meals including fruit.

nut diet

Dietary Supplement

Participants will consume assigned standardized meals including nut.

calcium supplement diet

Dietary Supplement

Participants will consume assigned standardized meals including calcium supplements.

DASH diet

Dietary Supplement

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

Primary outcomes

  1. Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis

    Time frame: 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.

Secondary outcomes

  1. Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the high-fruit dietary intervention

    Time frame: 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 measured in urine samples collected at baseline and at 1, 2, 3, and 4 hours after the high-fruit dietary intervention, reported using protocol-defined units.

  2. Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the high-nut dietary intervention

    Time frame: 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 measured in urine samples collected at baseline and at 1, 2, 3, and 4 hours after the high-nut dietary intervention, reported using protocol-defined units.

  3. Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the calcium supplementation dietary intervention

    Time frame: 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 measured in urine samples collected at baseline and at 1, 2, 3, and 4 hours after the calcium supplementation dietary intervention, reported using protocol-defined units.

  4. Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following the DASH dietary intervention

    Time frame: Baseline and daily for up to 2 weeks during the DASH dietary intervention.

    Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels measured in urine samples collected at baseline and daily during the DASH dietary intervention, reported using protocol-defined units.

  5. Within-participant variability in urinary sodium, chloride, potassium, magnesium, and calcium levels under free-living conditions

    Time frame: Daily for up to 1 week under free-living conditions.

    Within-participant variability in urinary sodium, chloride, potassium, magnesium, and calcium levels measured in urine samples collected under free-living conditions without a protocol-defined dietary intervention, reported as the within-participant coefficient of variation.

Study contacts

Contact information is provided by the study sponsor or research team.

Haisong LIN

CONTACT

[email protected]

+86 18503060398

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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