- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04142138
When the Kidney Reacts to Nutritional Changes
Translational Characterization of Blood Pressure Changes Following the Dietary Approach to Stop Hypertension (DASH) Diet- From Nutrition Through Electrolytes to Exosomes.
Study Overview
Detailed Description
Diet is a major disease modifier of hypertension. The Dietary Approaches to Stop Hypertension diet (DASH) is endorsed nationally and abroad to treat hypertension (HTN) in adults. In the original DASH study, the effect of the combination diet consisting of low salt, high potassium, and low-fat dairy products, was more pronounced in hypertensives and minorities. The magnitude of the effect on blood pressure (BP) of the combination diet was similar to that observed with single drug antihypertensive therapy.
Americans typically consume 3400 mg sodium daily, due to high intakes of processed foods, frequent eating outside the home, and consumption of packaged meals and salty snack foods. Foods consumed outside of the home provide 34% of the sodium intake of Americans.
It is not known exactly how the DASH diet effects its lowering of blood pressure. One of the proposed mechanism of the effect of the DASH diet relies on two components - sodium reduction and potassium supplementation.
In response to potassium supplementation such as in DASH diet, we would expect less sodium to be reabsorbed.
Over the years, adherence to DASH diet has been evaluated using questionnaires. Methods for monitoring sodium intake remain inadequate and flawed. Dietary recall is not reliable, and many patients truly do not realize, and consequently under report, the amount of sodium they consume. The most widely employed method of assessing dietary adherence, the 24-h urine collection to measure sodium excretion, is cumbersome and inconvenient. Evaluating urine sodium to creatinine ratio was validated as a surrogate measure to 24-hour urine collection .
Exosomes: most of the data regarding tissue activity of different channels in response to stimuli, comes from animal studies. Translation of the murine experimental findings to a human setting is difficult and has mostly been inferred using plasma and urinary electrolyte levels as a proxy for renal tubular transporter activity. Transporter proteins from all tubular segments are excreted into the urine in extracellular vesicles. These vesicles therefore provide a non-invasive liquid biopsy access to tubular epithelial cells that could potentially inform on physiological regulation of transporter activity in human kidneys . The proteins that are present in urine are a major area of investigation for proteomics researchers. In normal urine, typically half of the proteins are soluble proteins (49%), and the remaining 48% are sediment precipitated with low-speed centrifugation, and exosomes (3%). All exosomes contain a few common protein components. The cytosolic proteins present on exosomes include annexins, adhesion molecules, proteins that participate in vesicle formation and trafficking and metabolic enzymes. Analysis of urine exosomes can enhance the detectability of relatively low-abundant proteins that have potential pathophysiological significance, and so have become one of the newer trends in the field of urine-biomarker discovery .
Volunteers with hypertension stage 1, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days. Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals. During hospitalization blood and urine samples will be collected daily, as well as clinical parameters such as blood pressure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- The Rockefeller University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- any gender, 18-60 years of age
- self described as White or Black individuals
- prehypertensives (=stage 1 hypertension) defined as sustolic blood pressure of 130-159 mmHG and/or diastolic blood pressure between 80-100.
- adequate dentition to consume fruits and vegetables as described for DASH -
Exclusion Criteria:
- Preexisting kidney disease structural or parenchymal including APCKD (adult polycystic kidney disease), single kidney (as assessed by ultrasound including size differences >3 cm in diameter between kidneys), or evidence of RAS (renal artery stenosis)
- Pregnant
- HIV
- taking medications for diabetes, hyperlipidemia, cardiac disease, Medications for birth control, psychiatirc conditions, and sleep are Ok. Vitamins and herbs are Ok if continued throughout the study. Thyroid meds are acceptable if the TSH is within normal limits.
- Diabetes as defined by hemoglobin A1c > 6.5% and/or fasting glucose > 125 mg/dl
- Hyperlipidemia as defined by triglycerides >200 and/or LDL > 150
- Hematuria on screening
- RAAS (Renin-Angiotensin-Aldosterone) axis deviation - Aldosterone and Renin should be within normal ranges upon screening.
- BUN > 40mg/dL corrected to body surface area
- Creatinine > 1.3 mg/dL corrected to body surface area
- BMI > 29.9 or < 19
- Current smoker
- Currently, a vegetarian (who does not consume fish and dairy) or a vegan
- Based on medical history, any evidence of an autoimmune disease
- Use of any of the following - ACEi, ARB, spironolactone, diuretics of any class, beta blockers, alpha blockers, nsaids, within the past two weeks
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: nutrition implementation
Volunteers with prehypertension, but otherwise healthy, will complete a screening visit, then be admitted to the In-Patient Unit for fourteen (14) days.
Participants will be admitted for 5 days during the week and then go on pass for 2 weekend days each week with packed DASH diet meals.
During hospitalization we will: 1) collect samples of blood and urine daily 2) monitor blood pressure, weight and pulse twice daily 3) collect 24-hour urine, twice during the period of two weeks 4) serve participants a menu based on DASH principles, namely low in sodium and high in potassium.
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DASH diet is based on low salt, high potassium components, and is comprised of mainly fruits and vegetables.
During hospitalization we will collect laboratory data of blood and urine, and follow participants clinically by measuring blood pressure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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urine exosome protein abundance pattern
Time Frame: Day 1 and Day 12
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Mass spectrometry generates a list of proteins for each sample.
We will compare fold of change before (Day 1) and after intervention (Day 12) - a true change is defined as 1.5 fold.
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Day 1 and Day 12
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urine electrolyte ratio in a spot urine as a surrogate to 24-h urine collection to assess nutritional consumption.
Time Frame: day 1,2,3,4,5,6,8,9,10,11,12,14
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spot urine will be analyzed for sodium and potassium parallel to 24-h urine collection.
We will assess the concordance between the 24-h collection and the spot urine ratio of electrolytes.
The result will be presented as a ratio of SPOT ratio (sodium/potassium) to 24-h collection ratio (sodium/potassium), for each participant.
We will assess how close the ratio of ratios is to one.
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day 1,2,3,4,5,6,8,9,10,11,12,14
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24-h urine collection as a measure of adherence to the DASH diet
Time Frame: day 1, 12
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Urine will be collected throughout 24 hours to analyze electrolyte content, during intervention - twice, at the beginning (day 1) and end of intervention (day 12).
We will be measuring daily sodium excretion, the threshold for compliance will be equal to or less than 100MEQ/d.
For potassium daily excretion the threshold will be greater than or equal to 90meq/d .
The change will be reported as number of participants that have met the defined threshold for compliance.
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day 1, 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dana Bielopolski, MD PhD, The Rockefeller University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBI-1000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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