Healthy
Conditions
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.
Interventions
DEVICEUrinary electrolyte
Urine is collected and tested on the device.
DIETARY_SUPPLEMENTfruit diet
Participants will consume assigned standardized meals including fruit.
DIETARY_SUPPLEMENTnut diet
Participants will consume assigned standardized meals including nut.
DIETARY_SUPPLEMENTcalcium supplement diet
Participants will consume assigned standardized meals including calcium supplements.
DIETARY_SUPPLEMENTDASH diet
Participants will consume assigned low salt high fruit meals following DASH diet guidance.
Sponsors
Westlake University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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 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. |
| 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. | 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. |
| 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. | 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. |
Countries
China
Outcome results
None listed