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Effectiveness of the DASH Diet at Reducing High Blood Pressure

Primary Purpose

Cardiovascular Diseases, Hypertension, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary Approaches to Stop Hypertension (DASH)
Control Diet
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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90 mm Hg Body mass index (BMI) less than 40 Current use of fewer than two blood pressure medications (which will be withdrawn prior to study) Exclusion Criteria: Major concomitant diseases that may include but are not limited to active pulmonary disease within the past 6 months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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Dietary Approaches to Stop Hypertension (DASH)

    Control diet

    Outcomes

    Primary Outcome Measures

    Changes in central aortic stiffness, diastolic relaxation, renal blood flow,and vascular response to Ang II

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2005
    Last Updated
    January 12, 2016
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00123006
    Brief Title
    Effectiveness of the DASH Diet at Reducing High Blood Pressure
    Official Title
    Cardiovascular and Renal Hemodynamics and the DASH Diet
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Hypertension, Heart Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Dietary Approaches to Stop Hypertension (DASH)
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Control diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dietary Approaches to Stop Hypertension (DASH)
    Intervention Description
    4 week feeding intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control Diet
    Intervention Description
    4 week feeding intervention
    Primary Outcome Measure Information:
    Title
    Changes in central aortic stiffness, diastolic relaxation, renal blood flow,and vascular response to Ang II
    Time Frame
    Measured at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul R. Conlin, MD
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31528838
    Citation
    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.
    Results Reference
    derived

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    Effectiveness of the DASH Diet at Reducing High Blood Pressure

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