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Tracking Information | |||||
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First Received Date ICMJE | November 19, 2009 | ||||
Last Updated Date | November 19, 2009 | ||||
Start Date ICMJE | July 2007 | ||||
Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
urinary sodium [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
blood pressure [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Mechanism of the Blood Pressure Lowering Effect of the DASH Dietary Pattern | ||||
Official Title ICMJE | Mechanism of the Blood Pressure Lowering Effect of the DASH Dietary Pattern | ||||
Brief Summary | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
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Condition ICMJE | Blood Pressure | ||||
Intervention ICMJE | Other: DASH, Control
controlled feeding of either the DASH dietary pattern or a typical American diet at isocaloric level. |
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Study Arms |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 20 | ||||
Completion Date | June 2009 | ||||
Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 22 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01017484 | ||||
Other Study ID Numbers ICMJE | AHA 0755460U | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Pao-Hwa Lin, Duke University Medical Center | ||||
Study Sponsor ICMJE | Duke University | ||||
Collaborators ICMJE | American Heart Association | ||||
Investigators ICMJE |
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Information Provided By | Duke University | ||||
Verification Date | November 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |