Translational Characterization of Blood Pressure Changes Following the Dietary Approach to Stop Hypertension (DASH) Diet- From Nutrition Through Electrolytes to Exosomes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rockefeller University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- urine exosome protein abundance pattern
Study Overview
Brief Summary
Hypertension is one of the leading causes of morbidity and mortality in the industrialized world, attributed mostly to modifiable lifestyle factors. Aspects that are controlled by patients include physical activity, smoking, alcohol consumption, and nutrition. The DASH (Dietary Approach to Stop Hypertension) diet is a proven effective intervention in lowering blood pressure in multiple populations. In this proof of concept study, volunteers with untreated stage 1 hypertension, defined as mild high blood pressure with numbers in the range of 130 - 139 over 80 - 89, will receive a DASH-based menu during 5 days of hospitalization, during a weekend at home where they will continue the menu, another 5 days as inpatients, followed by a weekend at home on the same menu, and the return to the inpatient unit for an additional day for final testing. Throughout the intervention period, participants will be followed clinically and undergo repeated laboratory testing. The aim of this project is to characterize changes in urine electrolytes and exosome protein abundance pattern during nutritional changes, shifting from a "westernized diet" to a DASH diet.
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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)
- •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
Outcomes
Primary Outcomes
urine exosome protein abundance pattern
Time Frame: Day 1 and Day 12
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.
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
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.
24-h urine collection as a measure of adherence to the DASH diet
Time Frame: day 1, 12
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.
Secondary Outcomes
No secondary outcomes reported