HypertensionNCT02059811
Efficacy and Safety of the DASH Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study
A study testing DASH Diet in people with Hypertension and Chronic Kidney Disease, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Chronic Kidney Disease
- What is being tested?
- DASH Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stedman Nutrition and Metabolism Center, Center for Living
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Chronic Kidney Disease
- Being tested
- DASH Diet, Control Diet
- Keywords
- Kidney Diseases, Renal Insufficiency, Chronic, Diet, DASH diet, Hypertension, Vascular diseases, Cardiovascular Diseases, Blood pressure
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic, Kidney Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH DietOther
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 DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: DASH Diet; Other: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office systolic blood pressure
A comparison of pre-intervention and post-intervention systolic blood pressure will be completed.
Measured: 2 weeks post DASH diet intervention
Secondary outcomes (1)
Change in serum potassium
A comparison of pre-intervention and post-intervention serum potassium will be completed.
Measured: 2 weeks post DASH diet intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crystal Tyson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059811
- Sponsor's protocol ID
- Pro00048112
- Status last verified
- Oct 2014
- First submitted
- 7 Feb 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Dietary Approaches to Stop Hypertension (DASH) Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study
- ClinicalTrials.gov ID
- NCT02059811
- Acronym / sponsor ID
- Pro00048112
- Conditions
- Hypertension, Chronic Kidney Disease
- Keywords
- Kidney Diseases, Renal Insufficiency, Chronic, Diet, DASH diet, Hypertension, Vascular diseases, Cardiovascular Diseases, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DASH Diet | Experimental | Other: DASH Diet, Other: Control DietAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH DietThe 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 | DASH Diet |
| Control DietThe 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. | Other | DASH Diet |
Primary outcome
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.
1 secondary outcome
Change in serum potassium
Time frame: 2 weeks post DASH diet intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Tyson, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH Diet in people with Hypertension and Chronic Kidney Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic blood pressure (time frame: 2 weeks post DASH diet intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.