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CompletedNCT01017484Updated Apr 11, 2013

Mechanism of the Blood Pressure Lowering Effect of the DASH Dietary Pattern

An interventional study of DASH, Control in Blood Pressure, sponsored by Duke University. Completed. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-11.

Sponsored by Duke University · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Blood Pressure

Keywords

  • blood pressure
  • DASH diet
  • hypertension
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. SBP 140-159 mm Hg and DBP 90-99 mm Hg based on mean values over two screening visits,
  2. Age ≥22 years, and
  3. 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

Exclusion Criteria:

  1. Any serious illness that would interfere with participation or make DASH diet unsafe to the participants,
  2. Currently on cancer chemotherapy or with evidence of active malignancy or radiation therapy within past six months,
  3. History of CVD event (MI, CABG, angioplasty, symptomatic ischemic heart disease, or stroke),
  4. Clinical diagnosis of congestive heart failure,
  5. Current diagnosis of diabetes and treatment for diabetes with oral medication or insulin,
  6. Body mass index > 45 Kg/m2,
  7. DASH MECHANISM staff or household member of DASH MECHANISM staff,
  8. 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;
  9. Consumption of more than 14 alcoholic drinks per week;
  10. Investigator discretion for safety or compliance reasons;
  11. Inability to provide reliable BP \& vascular functions measurements;
  12. Planning to leave the area prior to the anticipated end of the intervention period;
  13. Pregnant, planning a pregnancy prior to the end of intervention, or breast feeding;
  14. Significant food allergies, preferences, or dietary requirements that would interfere with diet adherence; and
  15. Subjects taking medications for erectile dysfunction.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    DASH

    The Dietary Approaches to Stop Hypertension Dietary pattern.

    Other: DASH, Control

  • Experimental
    Control

    The typical American diet as estimated from the NHANES survey.

    Other: DASH, Control

Interventions

  • OtherDASH, Control

    controlled feeding of either the DASH dietary pattern or a typical American diet at isocaloric level.

06

What researchers measure

Primary outcomes

  1. urinary sodium

    Time frame: 2 weeks

Secondary outcomes

  1. blood pressure

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01017484
Lead sponsor
Duke University
Collaborators
American Heart Association
Responsible party
Sponsor
First posted
Nov 20, 2009
Start date
Jul 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Apr 11, 2013

Study contacts

Pao-Hwa Lin, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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