NCT00123006

Brief Summary

The purpose of this study is to test the effects of the DASH diet in patients with isolated systolic hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

3.4 years

First QC Date

July 20, 2005

Last Update Submit

January 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Measured at 4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Dietary Approaches to Stop Hypertension (DASH)

Behavioral: Dietary Approaches to Stop Hypertension (DASH)

2

PLACEBO COMPARATOR

Control diet

Behavioral: Control Diet

Interventions

4 week feeding intervention

1
Control DietBEHAVIORAL

4 week feeding intervention

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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  • Current use of fewer than two blood pressure medications (which will be withdrawn prior to study)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionHeart Diseases

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Paul R. Conlin, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

October 1, 2014

Last Updated

January 13, 2016

Record last verified: 2016-01