When the Kidney Reacts to Nutritional Changes

Completed · Not applicable

Conditions studied: Prehypertension

In brief

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.

Key facts

Study ID

NCT04142138

Run by

Rockefeller University

People needed

9

Starts

2020-02-22

Expected to finish

2021-04-30

Last updated by the study team

2021-08-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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

Where it is running

• The Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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