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

NCT02059811 | Completed

• 1 other identifier: Pro00048112
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Chronic Kidney Disease

Keywords

Kidney Diseases; Renal Insufficiency, Chronic; Diet; DASH diet; Hypertension; Vascular diseases; Cardiovascular Diseases; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in office systolic blood pressure

  A comparison of pre-intervention and post-intervention systolic blood pressure will be completed.

  2 weeks post DASH diet intervention

Secondary Outcomes (1)

• Change in serum potassium

  2 weeks post DASH diet intervention

Other Outcomes (6)

• Change in blood pressure

  2 weeks post DASH diet intervention

• Change in markers of kidney function

  2 weeks post DASH diet intervention

• Change in markers of mineral metabolism

  2 weeks post DASH diet intervention

Study Arms (1)

DASH Diet

EXPERIMENTAL

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.

Other: DASH Diet; Other: Control Diet

Interventions

DASH Diet 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.

DASH Diet

Control Diet 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.

DASH Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Stedman Nutrition and Metabolism Center, Center for Living

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic; Kidney Diseases; Vascular Diseases; Cardiovascular Diseases

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Crystal Tyson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

US (1)