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| ID | Type | Description | Link |
|---|---|---|---|
| 20260521LHS001 | Other Identifier | Westlake University |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fruit diet (for potassium intake) | Experimental |
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| nut diet (for magnesium intake) | Experimental |
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| Calcium supplement diet (for calcium intake) | Experimental |
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| DASH Diet (for low-salt and high-fruit intake) | Experimental |
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| Uncontrol | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary electrolyte | Device | Urine is collected and tested on the device. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following 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. | Baseline, 1 hour, 2 hours, 3 hours, and 4 hours after the high-fruit dietary intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haisong LIN | Contact | +86 18503060398 | linhaisong@westlake.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westlake University | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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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.
| fruit diet | Dietary Supplement | Participants will consume assigned standardized meals including fruit. |
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| nut diet | Dietary Supplement | Participants will consume assigned standardized meals including nut. |
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| calcium supplement diet | Dietary Supplement | Participants will consume assigned standardized meals including calcium supplements. |
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| DASH diet | Dietary Supplement | Participants will consume assigned low salt high fruit meals following DASH diet guidance. |
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| Change from baseline in urinary sodium, chloride, potassium, magnesium, and calcium levels following 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. | 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 | 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. | 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 | 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. | 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 | 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. | Daily for up to 1 week under free-living conditions. |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |