The Effects of Pork vs. Chicken/Fish in a DASH Diet on Bl... | NCT01696097

Studies
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults

NCT01696097

Sponsor

Purdue University

Status

Completed

Last Update Posted

Aug 17, 2015Estimated

Enrollment

19Actual

Phase

Not Applicable

Conditions

Hypertension
Dyslipidemias

Interventions

DASH diet counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S31 Campbell Lab	Other Identifier	Purdue University

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Sep 26, 2012

First Submission Date that Met QC Criteria

Sep 26, 2012

First Posted Date

Sep 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2015

Last Update Posted Date

Aug 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

High blood pressure is a major risk factor for heart disease and stroke and affects 50 million people in the United States. Making healthy food choices, such as those in the DASH (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure control in people with high blood pressure. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dietary Counseling	Other	Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure	Behavioral: DASH diet counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DASH diet counseling	Behavioral	Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.	Dietary Counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in blood pressure		After 6 weeks of following DASH diet

Secondary Outcomes

Measure	Description	Time Frame
Change in blood lipids		After 6 weeks of following DASH diet

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wayne W Campbell, Ph. D.	Purdue University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Purdue University		West Lafayette	Indiana	47907	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26063693	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D006973	Hypertension
D050171	Dyslipidemias