Dynamic Monitoring of Urinary Electrolytes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urinary electrolyte, fruit diet, nut diet, calcium supplement diet.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Prototype Device Valid Measurement Rate for Urinary Electrolyte Analysis [Time frame: Up to 2 weeks after study arm assignment.]
Secondary outcome measures (5)
- 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 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 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 following the DASH dietary intervention [Time frame: 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 [Time frame: Daily for up to 1 week under free-living conditions.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Device feasibility
Study locations
China · 1 center
- Westlake University — Hangzhou
Identifiers
NCT: NCT07704450 · 20260114LHS001 · 20260521LHS001