Efficacy and Safety of the DASH Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study

NCT ID: NCT02059811

Last Updated: 2014-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Hypertension; Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DASH Diet

All participants will be provided a control diet for a 7-day run-in period followed by the DASH dietary intervention for a 14-day intervention period. Participants will consume the largest meal of the day in a supervised setting at the study center and all other meals and snacks will be provided in "to-go" packages. Weight will be held constant by measuring participant weight daily and adjusting caloric content of meals. Adherence will be monitor by review of daily food diaries.

Group Type: EXPERIMENTAL

DASH Diet

Intervention Type: OTHER

The DASH diet is a nutritional intervention that is low in cholesterol and saturated fat and emphasizes high intake of the following: fruits, vegetables, low-fat dairy products, whole grains, fiber, and protein derived mostly from plant sources.

Control Diet

Intervention Type: OTHER

The control diet, which is a diet typical of most Americans, is relatively high in total and saturated fat and cholesterol, and low in servings of fruits, vegetables and low fat dairy products.

Interventions

DASH Diet

The DASH diet is a nutritional intervention that is low in cholesterol and saturated fat and emphasizes high intake of the following: fruits, vegetables, low-fat dairy products, whole grains, fiber, and protein derived mostly from plant sources.

Intervention Type: OTHER

Control Diet

The control diet, which is a diet typical of most Americans, is relatively high in total and saturated fat and cholesterol, and low in servings of fruits, vegetables and low fat dairy products.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥18 years old
• eGFR 30-59 ml/min/1.73m2
• SBP ≥ 130 mmHg or DBP ≥ 80 mmHg
• willing to eat one meal on-site 5 days/week

Exclusion Criteria

• baseline potassium >4.6 mEq/L while not taking potassium supplements (if potassium is ≥ 5.0 while taking potassium supplements, a potassium of 4.6 or less must be demonstrated off supplements
• 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
• 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 aldosterone antagonist
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crystal Tyson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Stedman Nutrition and Metabolism Center, Center for Living

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00048112

Identifier Type: -

Identifier Source: org_study_id