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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL128909-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This cross-over clinical trial is being conducted to evaluate the difference in urinary messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a low-sodium diet, as compared to a high-sodium diet. The study team will collect urine and blood samples from each participant to study mineralocorticoid receptor-regulated mRNA biomarkers following the consumption of each diet.
The study team will instruct the participants to consume 8 days each of high- (300 mmol/day) and low- (10 mmol/day) sodium meals. The order in which the participants will eat the two study diets will be randomly determined. In between the high- and low-sodium diets, the participants will have a wash-out period of 6 days, during which they will be encouraged to consume their usual diet. Participants will be asked to provide the study team with 24-hour urine samples, random urine samples, and blood samples throughout their participation in this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High sodium diet | Experimental |
| |
| Low sodium diet | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-sodium diet 300 mmol sodium/day | Other | Day 7 or day 21 high-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary mineralocorticoid receptor-regulated messenger RNA (mRNA) biomarker | Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR). | Day 15 (after first diet period) |
| Urinary mineralocorticoid receptor-regulated mRNA biomarker | Urinary mRNA biomarkers following consumption of a high-sodium and low-sodium diet will be measured using real-time quantitative polymerase chain reaction (RT-qPCR). | Day 29 (after second diet period) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet | Day 15 (after first diet period) |
| Blood pressure | Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet |
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Inclusion Criteria:
Normotensive, as defined by:
Willingness to refrain from intense exercise (for example, swimming, biking, running)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Brian Byrd, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
We will de-identify participant information and will share it with a trusted repository, such as National Institutes of Health (NIH) Figshare or The Inter-university Consortium for Political and Social Research (ICPSR).
We will de-identify and share data obtained from analyzing urinary mRNA biomarkers and measuring the systolic and diastolic blood pressure following consumption of a high-sodium and low-sodium diet. Additionally, specific lab values that support the validity and quality of the study treatment will be shared in a trusted repository.
De-identified data will be deposited into a repository within 1 year of the conclusion of the study.
No additional access restrictions will be placed on the de-identified data, beyond those required by the repository to access or download the data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2021 | Dec 16, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Low-sodium diet 10 mmol sodium/day | Other | Day 7 or day 21 low-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team. |
|
| Day 29 (after second diet period) |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |