- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02059811
Efficacy and Safety of the DASH Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study
Efficacy and Safety of the Dietary Approaches to Stop Hypertension (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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Stedman Nutrition and Metabolism Center, Center for Living
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in office systolic blood pressure
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention systolic blood pressure will be completed.
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2 weeks post DASH diet intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum potassium
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention serum potassium will be completed.
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2 weeks post DASH diet intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention office diastolic blood pressure and 24 hour ambulatory systolic and diastolic blood pressure will be completed.
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2 weeks post DASH diet intervention
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Change in markers of kidney function
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention markers of kidney function (creatinine, eGFR, and urine albumin-to-creatinine ratio) will be completed.
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2 weeks post DASH diet intervention
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Change in markers of mineral metabolism
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention markers of mineral metabolism (calcium, phosphorus, intact parathyroid hormone, and 25-hydroxyvitamin D) will be completed.
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2 weeks post DASH diet intervention
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Change in serum electrolytes
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention electrolytes (bicarbonate, urea nitrogen) will be completed.
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2 weeks post DASH diet intervention
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Change in fasting glucose
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention fasting glucose will be completed.
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2 weeks post DASH diet intervention
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Change in 24 hour urinary excretion
Time Frame: 2 weeks post DASH diet intervention
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A comparison of pre-intervention and post-intervention urinary excretion of sodium, potassium, urea nitrogen, calcium, phosphorus, magnesium, creatinine, and albumin will be completed.
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2 weeks post DASH diet intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Crystal Tyson, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00048112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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