An interventional study of High-sodium diet 300 mmol sodium/day and Low-sodium diet 10 mmol sodium/day in Healthy, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
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.
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Normotensive, as defined by:
Exclusion Criteria:
Other: High-sodium diet 300 mmol sodium/day
Other: Low-sodium diet 10 mmol sodium/day
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.
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.
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).
Time frame: 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).
Time frame: Day 29 (after second diet period)
Blood pressure
Systolic and diastolic blood pressure measurement following consumption of a high-sodium compared to a low-sodium diet
Time frame: 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
Time frame: Day 29 (after second diet period)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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