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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02059811
First received: February 7, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Hypertension
Chronic Kidney Disease
Other: DASH Diet
Other: Control Diet

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Dietary Approaches to Stop Hypertension (DASH) Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in office systolic blood pressure [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
    A comparison of pre-intervention and post-intervention systolic blood pressure will be completed.


Secondary Outcome Measures:
  • Change in serum potassium [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
    A comparison of pre-intervention and post-intervention serum potassium will be completed.


Other Outcome Measures:
  • Change in blood pressure [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
    A comparison of pre-intervention and post-intervention office diastolic blood pressure and 24 hour ambulatory systolic and diastolic blood pressure will be completed.

  • Change in markers of kidney function [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
    A comparison of pre-intervention and post-intervention markers of kidney function (creatinine, eGFR, and urine albumin-to-creatinine ratio) will be completed.

  • Change in markers of mineral metabolism [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention markers of mineral metabolism (calcium, phosphorus, intact parathyroid hormone, and 25-hydroxyvitamin D) will be completed.

  • Change in serum electrolytes [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention electrolytes (bicarbonate, urea nitrogen) will be completed.

  • Change in fasting glucose [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention fasting glucose will be completed.

  • Change in 24 hour urinary excretion [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention urinary excretion of sodium, potassium, urea nitrogen, calcium, phosphorus, magnesium, creatinine, and albumin will be completed.


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059811

Locations
United States, North Carolina
Stedman Nutrition and Metabolism Center, Center for Living Recruiting
Durham, North Carolina, United States, 27705
Contact: Crystal Tyson, MD    919-660-6671    cs206@dm.duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Crystal Tyson, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02059811     History of Changes
Other Study ID Numbers: Pro00048112
Study First Received: February 7, 2014
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Kidney Diseases
Renal Insufficiency, Chronic
Diet
DASH diet
Hypertension
Vascular diseases
Cardiovascular Diseases
Blood pressure

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 19, 2014