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

Primary Purpose

Hypertension, Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DASH Diet

Control Diet

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Kidney Diseases, Renal Insufficiency, Chronic, Diet, DASH diet, Hypertension, Vascular diseases, Cardiovascular Diseases, Blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stedman Nutrition and Metabolism Center, Center for Living

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DASH Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in office systolic blood pressure

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

Secondary Outcome Measures

Change in serum potassium

A comparison of pre-intervention and post-intervention serum potassium will be completed.

Full Information

NCT ID

NCT02059811

First Posted

February 7, 2014

Last Updated

October 2, 2014

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02059811

Brief Title

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

Official Title

Efficacy and Safety of the Dietary Approaches to Stop Hypertension (DASH) Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Chronic Kidney Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DASH Diet

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

DASH Diet

Intervention Description

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

Intervention Name(s)

Control Diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in office systolic blood pressure

Description

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

Time Frame

2 weeks post DASH diet intervention

Secondary Outcome Measure Information:

Title

Change in serum potassium

Description

A comparison of pre-intervention and post-intervention serum potassium will be completed.

Time Frame

2 weeks post DASH diet intervention

Other Pre-specified Outcome Measures:

Title

Change in blood pressure

Description

A comparison of pre-intervention and post-intervention office diastolic blood pressure and 24 hour ambulatory systolic and diastolic blood pressure will be completed.

Time Frame

2 weeks post DASH diet intervention

Title

Change in markers of kidney function

Description

A comparison of pre-intervention and post-intervention markers of kidney function (creatinine, eGFR, and urine albumin-to-creatinine ratio) will be completed.

Time Frame

2 weeks post DASH diet intervention

Title

Change in markers of mineral metabolism

Description

A comparison of pre-intervention and post-intervention markers of mineral metabolism (calcium, phosphorus, intact parathyroid hormone, and 25-hydroxyvitamin D) will be completed.

Time Frame

2 weeks post DASH diet intervention

Title

Change in serum electrolytes

Description

A comparison of pre-intervention and post-intervention electrolytes (bicarbonate, urea nitrogen) will be completed.

Time Frame

2 weeks post DASH diet intervention

Title

Change in fasting glucose

Description

A comparison of pre-intervention and post-intervention fasting glucose will be completed.

Time Frame

2 weeks post DASH diet intervention

Title

Change in 24 hour urinary excretion

Description

A comparison of pre-intervention and post-intervention urinary excretion of sodium, potassium, urea nitrogen, calcium, phosphorus, magnesium, creatinine, and albumin will be completed.

Time Frame

2 weeks post DASH diet intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Crystal Tyson, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stedman Nutrition and Metabolism Center, Center for Living

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

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

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