Efficacy and Safety of the DASH Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | February 2014 |
| End Date: | June 2014 |
Efficacy and Safety of the Dietary Approaches to Stop Hypertension (DASH) Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study
More than two-thirds of US adults with chronic kidney disease (CKD) have uncontrolled
hypertension. Both hypertension and CKD are major independent risk factors for
cardiovascular disease, which is the leading cause of death in the US. Fortunately,
lowering blood pressure to recommended treatment targets not only slows the progression of
CKD, but also improves cardiovascular outcomes. Controlling hypertension in this patient
population, however, can be quite challenging. A lifestyle modification that effectively
reduces blood pressure in both pre-hypertensive and hypertensive adults is the Dietary
Approaches to Stop Hypertension (DASH) diet.
The purpose of this pilot study is to (1) determine the extent to which the DASH diet lowers
blood pressure in hypertensive adults with moderate chronic kidney disease (CKD) (estimated
glomerular filtration rate [eGFR] 30-59 ml/min/1.73m2) and (2) establish that the DASH diet
can be safely consumed by this patient population.
hypertension. Both hypertension and CKD are major independent risk factors for
cardiovascular disease, which is the leading cause of death in the US. Fortunately,
lowering blood pressure to recommended treatment targets not only slows the progression of
CKD, but also improves cardiovascular outcomes. Controlling hypertension in this patient
population, however, can be quite challenging. A lifestyle modification that effectively
reduces blood pressure in both pre-hypertensive and hypertensive adults is the Dietary
Approaches to Stop Hypertension (DASH) diet.
The purpose of this pilot study is to (1) determine the extent to which the DASH diet lowers
blood pressure in hypertensive adults with moderate chronic kidney disease (CKD) (estimated
glomerular filtration rate [eGFR] 30-59 ml/min/1.73m2) and (2) establish that the DASH diet
can be safely consumed by this patient population.
During a 7-day run-in phase, participants will first consume a control diet similar in
nutrient composition to the control diet of previous DASH studies. The control diet, which
is a diet typical of most Americans, is reduced in servings of fruits, vegetables, low fat
dairy products and relatively high in total and saturated fat. Immediately following the
run-in phase, participants will receive the DASH diet during a 14-day intervention phase.
Both diets will have the same sodium content and caloric intake will be adjusted for each
participant to keep weight stable. All study meals and snacks will be provided.
nutrient composition to the control diet of previous DASH studies. The control diet, which
is a diet typical of most Americans, is reduced in servings of fruits, vegetables, low fat
dairy products and relatively high in total and saturated fat. Immediately following the
run-in phase, participants will receive the DASH diet during a 14-day intervention phase.
Both diets will have the same sodium content and caloric intake will be adjusted for each
participant to keep weight stable. All study meals and snacks will be provided.
Inclusion Criteria:
- ≥18 years old
- eGFR 30-59 ml/min/1.73m2
- SBP 140-179 mmHg or DBP 90-99 mmHg
- willing to eat one meal on-site 5 days/week
Exclusion Criteria:
- baseline potassium >4.6 mEq/L
- evidence of hyperkalemia (>5.1 mEq/L) within last 6 months
- ≥ 0.5 mg/dl increase in serum creatinine in past 6 months
- albumin-to-creatinine ratio > 200 mg/mmol
- insulin requiring or poorly controlled diabetes mellitus
- cardiovascular event within previous 6 months
- body mass index >45 kg/m2
- change in anti-hypertensive medications in last 2 weeks, or anticipated medication
change during study period
- unwillingness to eat only study food for 21 day study period
- unwillingness or inability to discontinue vitamin and mineral supplements or antacids
containing potassium, magnesium or calcium
- use of potassium sparing diuretics
- use of oral corticosteroids
- alcohol intake >14 drinks/week
- unstable doses of psychotropics or phenothiazine
- weight reducing medications
- use of medications for erectile dysfunction during study period
- pregnant, breast feeding, or planning pregnancy during study period
- chronic disease that may interfere with participation
- history of organ transplant
- any serious illness that would interfere with participation or make DASH diet unsafe
- planning to leave the area during the study period
- significant food allergies, preferences, or dietary requirements that would interfere
with diet adherence
- investigator discretion for safety or compliance reasons
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