HypertensionS31NCT01696097
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults
A study testing DASH diet counseling in people with Hypertension and Dyslipidemias, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension, Dyslipidemias
- What is being tested?
- DASH diet counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults (S31)
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.
Read the 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.
- Conditions
- Hypertension, Dyslipidemias
- Being tested
- DASH diet counseling
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH diet counselingBehavioural
Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Counseling | Other | Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Receives: Behavioral: DASH diet counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: After 6 weeks of following DASH diet
Secondary outcomes (1)
Change in blood lipids
Measured: After 6 weeks of following DASH diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, Ph. D., Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696097
- Sponsor's protocol ID
- 1112011665
- Other IDs
- S31 Campbell Lab
- Acronym
- S31
- Status last verified
- Aug 2015
- First submitted
- 26 Sep 2012
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26063693
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults (S31)
- ClinicalTrials.gov ID
- NCT01696097
- Acronym / sponsor ID
- S31 / 1112011665
- Conditions
- Hypertension, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Counseling | Other | Behavioral: DASH diet counselingPork vs. Chicken/Fish in a DASH Diet on Blood Pressure |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male or female
- age 40-75
- BMI 25-40 kg/m2
- systolic blood pressure 120-160 mm Hg
- diastolic blood pressure <100 mm Hg
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH diet counselingComparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids. | Behavioural | Dietary Counseling |
Primary outcome
Change in blood pressure
Time frame: After 6 weeks of following DASH diet
1 secondary outcome
Change in blood lipids
Time frame: After 6 weeks of following DASH diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Derived from this study: PubMed 26063693Sayer 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.
- DASH eating plan infoLink provided by the sponsor.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne W Campbell, Ph. D. principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet counseling in people with Hypertension and Dyslipidemias, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: After 6 weeks of following DASH diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.