- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017484
Mechanism of the Blood Pressure Lowering Effect of the DASH Dietary Pattern
April 9, 2013 updated by: Duke University
Understanding the possible mechanism(s) by which the DASH dietary pattern lowers blood pressure will potentially enhance the value of this dietary intervention by elucidating the conditions under which it will be most effective, identifying target populations, examining its impact on vascular health beyond blood pressure, and enhancing the investigators' understanding of the interactions among diet, blood pressure and vascular function.
In addition, results of this study may help to identify additional therapeutic targets.
Therefore, the overall goal of the proposed study is to determine the mechanism(s) by which the DASH dietary pattern lowers blood pressure by using a controlled feeding design.
Study Overview
Detailed Description
Randomized, controlled feeding trials have established the BP lowering effects of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, which emphasizes fruits, vegetables and low fat dairy and is low in saturated and total fat.
The DASH studies were designed to establish efficacy, not to determine mechanism of action.
Other studies suggest that the DASH diet may have effects on the renin-angiotensin-aldosterone system (RAAS).
These effects have not been directly evaluated, nor have other potential mechanisms of action such as effects on adrenergic tone, vascular function and inflammation.
The BP-lowering effect of the DASH dietary pattern was maximal after two weeks of controlled feeding, and was comparable in magnitude to antihypertensive medication among participants with stage 1 hypertension.
Understanding the possible mechanism(s) by which the DASH diet lowers BP will potentially enhance the value of this intervention by elucidating the conditions under which it will be most effective, identifying target populations, examining its impact on vascular health beyond BP, and enhancing our understanding of the interactions among diet, BP and vascular function.
In addition, results of this study may help to identify additional therapeutic targets.
Therefore, the overall goal of the proposed study is to determine the mechanism(s) by which the DASH diet lowers BP.
Our unifying hypothesis is that DASH diet lowers BP through effects on vascular function and sodium excretion, mediated through the effects on RAAS.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- SBP 140-159 mm Hg and DBP 90-99 mm Hg based on mean values over two screening visits,
- Age ≥22 years, and
- Willing to eat at least one on-site meal/day, five days/week, and willing to eat study diets and nothing else for the 3 weeks of controlled feeding.
Exclusion Criteria:
- Any serious illness that would interfere with participation or make DASH diet unsafe to the participants,
- Currently on cancer chemotherapy or with evidence of active malignancy or radiation therapy within past six months,
- History of CVD event (MI, CABG, angioplasty, symptomatic ischemic heart disease, or stroke),
- Clinical diagnosis of congestive heart failure,
- Current diagnosis of diabetes and treatment for diabetes with oral medication or insulin,
- Body mass index > 45 Kg/m2,
- DASH MECHANISM staff or household member of DASH MECHANISM staff,
- Using Medications including BP lowering drugs within the last three months, using lithium,insulin or oral diabetes medications, oral corticosteroids, unstable doses of psychotropics or phenothiazines, antacids or nutritional supplements unless they can be discontinued, or weight reducing medications;
- Consumption of more than 14 alcoholic drinks per week;
- Investigator discretion for safety or compliance reasons;
- Inability to provide reliable BP & vascular functions measurements;
- Planning to leave the area prior to the anticipated end of the intervention period;
- Pregnant, planning a pregnancy prior to the end of intervention, or breast feeding;
- Significant food allergies, preferences, or dietary requirements that would interfere with diet adherence; and
- Subjects taking medications for erectile dysfunction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DASH
The Dietary Approaches to Stop Hypertension Dietary pattern.
|
controlled feeding of either the DASH dietary pattern or a typical American diet at isocaloric level.
|
Experimental: Control
The typical American diet as estimated from the NHANES survey.
|
controlled feeding of either the DASH dietary pattern or a typical American diet at isocaloric level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
urinary sodium
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pao-Hwa Lin, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
November 19, 2009
First Submitted That Met QC Criteria
November 19, 2009
First Posted (Estimate)
November 20, 2009
Study Record Updates
Last Update Posted (Estimate)
April 11, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00001236
- AHA 0755460U (Other Identifier: AHA)
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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