Cardiovascular DiseasesNCT00123006
Effectiveness of the DASH Diet at Reducing High Blood Pressure
A study testing Dietary Approaches to Stop Hypertension (DASH) in people with Cardiovascular Diseases and Hypertension, run by Brigham and Women's Hospital.
Trial summary
The purpose of this study is to test the effects of the DASH diet in patients with isolated systolic hypertension. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Heart Diseases
- What is being tested?
- Dietary Approaches to Stop Hypertension (DASH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Oct 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated systolic hypertension: systolic blood pressure (SBP) in the range of 140-179 mm Hg and diastolic blood pressure (DBP) less than 90 mm Hg
- Body mass index (BMI) less than 40
- Current use of fewer than two blood pressure medications (which will be withdrawn prior to study)
Who cannot join
- Major concomitant diseases that may include but are not limited to active pulmonary disease within the past 6 months
- History of cardiovascular disorders such as angina, heart attack, heart failure, or stent placement
- Active gastrointestinal disease, including prior gastrointestinal surgery
- Renal disease with serum creatinine greater than 1.5 mg/dl (men) or 1.4 mg/dl (women)
- Insulin-dependent diabetes mellitus
- Current pregnancy
About this study
Official title: Cardiovascular and Renal Hemodynamics and the DASH Diet
The purpose of this study is to test the effects of the DASH diet in patients with isolated systolic hypertension.
Read the detailed description
BACKGROUND:
The study expands upon the findings of the Dietary Approaches to Stop Hypertension (DASH) study, which showed that a dietary pattern emphasizing fruits, vegetables, and low fat dairy products and overall reduced in total and saturated fat significantly lowers blood pressure (BP). The DASH diet is particularly effective in African Americans and in individuals with systolic hypertension. However, it is not known if the DASH diet affects the pathophysiology of the hypertensive process. Preliminary data support the possibility that the DASH diet interrupts the renin-angiotensin system. This raises the intriguing possibility that the DASH diet will favorably impact on cardiovascular and renal hemodynamics in patients with isolated systolic hypertension. Therefore, the central hypothesis of this study is that the DASH diet affects central aortic stiffness, diastolic relaxation, and renal and vascular reactivity to angiotensin II (Ang II) by lowering tissue renin-angiotensin system activity.
DESIGN NARRATIVE:
A randomized, crossover design will be used to compare the DASH diet to a control diet as defined in the original DASH protocol (NEJM 1997; 336:1117). Fifty-five community-dwelling individuals age 20 and older with systolic blood pressure (SBP) 140-179 mmHg and diastolic blood pressure (DBP) less than 90 mmHg will enter a 1-week run-in period eating both the control and DASH diets for 3-4 days each. Following this, participants will begin two 4-week intervention feeding periods receiving either the DASH diet or the control diet in random order. Clinical measurements will be taken at the conclusion of each 4-week feeding period.
Outcome measures: Specific measurements will include peripheral and renal vascular response to Ang II infusions, renal blood flow measured by para-aminohippurate (PAH) clearance, conduit vessel hemodynamics, and tissue Doppler imaging (TDI). At the end of each intervention feeding period, the clinical measurements will be made before and after acute administration of captopril, an angiotensin converting enzyme (ACE) inhibitor.
The study will test whether the DASH diet (1) lowers central aortic stiffness as measured by vascular impedance and carotid-femoral pulse wave velocity; (2) improves diastolic relaxation as measured by early diastolic myocardial velocities across the mitral valve (Ea); (3) vasodilates renal blood flow and enhances vascular responses to Ang II; and (4) affects central aortic stiffness, diastolic relaxation, renal blood flow, and renal and vascular reactivity to Ang II by altering target tissue responsiveness to Ang II similar to ACE inhibition.
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases
- Being tested
- Dietary Approaches to Stop Hypertension (DASH), Control Diet
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Approaches to Stop Hypertension (DASH)Behavioural
4 week feeding intervention
Control DietBehavioural
4 week feeding intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dietary Approaches to Stop Hypertension (DASH) Receives: Behavioral: Dietary Approaches to Stop Hypertension (DASH) |
| 2 | Placebo comparator | Control diet Receives: Behavioral: Control Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in central aortic stiffness, diastolic relaxation, renal blood flow,and vascular response to Ang II
Measured: Measured at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJan 2006
- Primary completionJun 2009
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Paul Conlin, MD, Brigham and Women's Hospital
- Investigators
- Paul R. Conlin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123006
- Sponsor's protocol ID
- 229
- Other IDs
- R01HL077234
- Status last verified
- Jan 2016
- First submitted
- 20 Jul 2005
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maris SA, Williams JS, Sun B, Brown S, Mitchell GF, Conlin PR. Interactions of the DASH Diet with the Renin-Angiotensin-Aldosterone System. Curr Dev Nutr. 2019 Jul 31;3(9):nzz091. doi: 10.1093/cdn/nzz091. eCollection 2019 Sep.
PubMed 31528838
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Renal Hemodynamics and the DASH Diet
- ClinicalTrials.gov ID
- NCT00123006
- Acronym / sponsor ID
- 229
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jul 2005 (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.
The purpose of this study is to test the effects of the DASH diet in patients with isolated systolic hypertension.
Detailed description
BACKGROUND:
The study expands upon the findings of the Dietary Approaches to Stop Hypertension (DASH) study, which showed that a dietary pattern emphasizing fruits, vegetables, and low fat dairy products and overall reduced in total and saturated fat significantly lowers blood pressure (BP). The DASH diet is particularly effective in African Americans and in individuals with systolic hypertension. However, it is not known if the DASH diet affects the pathophysiology of the hypertensive process. Preliminary data support the possibility that the DASH diet interrupts the renin-angiotensin system. This raises the intriguing possibility that the DASH diet will favorably impact on cardiovascular and renal hemodynamics in patients with isolated systolic hypertension. Therefore, the central hypothesis of this study is that the DASH diet affects central aortic stiffness, diastolic relaxation, and renal and vascular reactivity to angiotensin II (Ang II) by lowering tissue renin-angiotensin system activity.
DESIGN NARRATIVE:
A randomized, crossover design will be used to compare the DASH diet to a control diet as defined in the original DASH protocol (NEJM 1997; 336:1117). Fifty-five community-dwelling individuals age 20 and older with systolic blood pressure (SBP) 140-179 mmHg and diastolic blood pressure (DBP) less than 90 mmHg will enter a 1-week run-in period eating both the control and DASH diets for 3-4 days each. Following this, participants will begin two 4-week intervention feeding periods receiving either the DASH diet or the control diet in random order. Clinical measurements will be taken at the conclusion of each 4-week feeding period.
Outcome measures: Specific measurements will include peripheral and renal vascular response to Ang II infusions, renal blood flow measured by para-aminohippurate (PAH) clearance, conduit vessel hemodynamics, and tissue Doppler imaging (TDI). At the end of each intervention feeding period, the clinical measurements will be made before and after acute administration of captopril, an angiotensin converting enzyme (ACE) inhibitor.
The study will test whether the DASH diet (1) lowers central aortic stiffness as measured by vascular impedance and carotid-femoral pulse wave velocity; (2) improves diastolic relaxation as measured by early diastolic myocardial velocities across the mitral valve (Ea); (3) vasodilates renal blood flow and enhances vascular responses to Ang II; and (4) affects central aortic stiffness, diastolic relaxation, renal blood flow, and renal and vascular reactivity to Ang II by altering target tissue responsiveness to Ang II similar to ACE inhibition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Dietary Approaches to Stop Hypertension (DASH)Dietary Approaches to Stop Hypertension (DASH) |
| 2 | Placebo comparator | Behavioral: Control DietControl diet |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated systolic hypertension: systolic blood pressure (SBP) in the range of 140-179 mm Hg and diastolic blood pressure (DBP) less than 90 mm Hg
- Body mass index (BMI) less than 40
- Current use of fewer than two blood pressure medications (which will be withdrawn prior to study)
Key exclusion criteria (6 listed)
- Major concomitant diseases that may include but are not limited to active pulmonary disease within the past 6 months
- History of cardiovascular disorders such as angina, heart attack, heart failure, or stent placement
- Active gastrointestinal disease, including prior gastrointestinal surgery
- Renal disease with serum creatinine greater than 1.5 mg/dl (men) or 1.4 mg/dl (women)
- Insulin-dependent 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 |
|---|---|---|
| Dietary Approaches to Stop Hypertension (DASH)4 week feeding intervention | Behavioural | 1 |
| Control Diet4 week feeding intervention | Behavioural | 2 |
Primary outcome
Changes in central aortic stiffness, diastolic relaxation, renal blood flow,and vascular response to Ang II
Time frame: Measured at 4 weeks
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 13 Jan 2016.
- Derived from this study: PubMed 31528838Maris SA, Williams JS, Sun B, Brown S, Mitchell GF, Conlin PR. Interactions of the DASH Diet with the Renin-Angiotensin-Aldosterone System. Curr Dev Nutr. 2019 Jul 31;3(9):nzz091. doi: 10.1093/cdn/nzz091. eCollection 2019 Sep.
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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.
Paul R. Conlin, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Approaches to Stop Hypertension (DASH) in people with Cardiovascular Diseases and Hypertension, run by Brigham and Women's Hospital.
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 3 inclusion and 6 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Changes in central aortic stiffness, diastolic relaxation, renal blood flow,and vascular response to Ang II (time frame: Measured at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123006, which also lists 1 linked publication.
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 13 Jan 2016.