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NCT Number: NCT02059811

Efficacy and Safety of the 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stedman Nutrition and Metabolism Center, Center for Living

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in office systolic blood pressure

    Time frame: 2 weeks post DASH diet intervention

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

Secondary outcomes

  1. Change in serum potassium

    Time frame: 2 weeks post DASH diet intervention

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

Other outcomes

  1. Change in blood pressure

    Time frame: 2 weeks post DASH diet intervention

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

  2. Change in markers of kidney function

    Time frame: 2 weeks post DASH diet intervention

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

  3. Change in markers of mineral metabolism

    Time frame: 2 weeks post DASH diet intervention

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

  4. Change in serum electrolytes

    Time frame: 2 weeks post DASH diet intervention

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

  5. Change in fasting glucose

    Time frame: 2 weeks post DASH diet intervention

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

  6. Change in 24 hour urinary excretion

    Time frame: 2 weeks post DASH diet intervention

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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