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

NCT01017484 | Completed

• 2 other identifiers: Pro00001236AHA 0755460U
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure

Keywords

blood pressure; DASH diet; hypertension

Outcome Measures

Primary Outcomes (1)

• urinary sodium

  2 weeks

Secondary Outcomes (1)

• blood pressure

  2 weeks

Study Arms (2)

DASH

EXPERIMENTAL

The Dietary Approaches to Stop Hypertension Dietary pattern.

Other: DASH, Control

Control

EXPERIMENTAL

The typical American diet as estimated from the NHANES survey.

Other: DASH, Control

Interventions

DASH, Control OTHER

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

Control; DASH

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• American Heart Association: collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pao-Hwa Lin, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 11, 2013

Record last verified: 2009-11