NCT01696097

Brief Summary

The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

September 26, 2012

Last Update Submit

August 13, 2015

Conditions

HypertensionDyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    After 6 weeks of following DASH diet

Secondary Outcomes (1)

  • Change in blood lipids

    After 6 weeks of following DASH diet

Study Arms (1)

Dietary Counseling

OTHER

Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure

Behavioral: DASH diet counseling

Interventions

DASH diet counselingBEHAVIORAL

Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.

Dietary Counseling

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • age 40-75
  • BMI 25-40 kg/m2
  • systolic blood pressure 120-160 mm Hg
  • diastolic blood pressure \<100 mm Hg
  • non-diabetic, no acute illness
  • not following vigorous exercise program
  • urinary continence

You may not qualify if:

  • age \<40 or \>75
  • BMI \<25 or \>40 kg/m2
  • systolic blood pressure \<120 or \>160 mm Hg
  • diastolic blood pressure \>100 mm Hg
  • diabetic, acute illness
  • following vigorous exercise program
  • urinary incontinence
  • current smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • Sayer RD, Wright AJ, Chen N, Campbell WW. Dietary Approaches to Stop Hypertension diet retains effectiveness to reduce blood pressure when lean pork is substituted for chicken and fish as the predominant source of protein. Am J Clin Nutr. 2015 Aug;102(2):302-8. doi: 10.3945/ajcn.115.111757. Epub 2015 Jun 10.

    PMID: 26063693DERIVED

Related Links

MeSH Terms

Conditions

HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wayne W Campbell, Ph. D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Foods and Nutrition

Study Record Dates

First Submitted

September 26, 2012

First Posted

September 28, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

US(1)