- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05344287
Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans
April 28, 2022 updated by: Matthew Brothers, The University of Texas at Arlington
The Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans: A Cross-Sectional Study
The role of diet in preventing hypertension and cardiovascular diseases in African Americans, who have a much higher risk of developing these diseases, is not well understood.
Therefore, this project will investigate whether African Americans following a 100% plant-based diet have more optimal blood pressure, vascular function, and blood lipid profiles, along with lower systemic inflammation relative to African Americans following a typical American diet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Arlington, Texas, United States, 76019
- UT Arlington - Science and Engineering Innovation and Research Building
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample from the greater Dallas-Fort Worth Metroplex area.
Description
Inclusion Criteria:
- Self-identify as African American/Black
- Self-reported adherence to either a typical American diet (not following a specific diet pattern) or 100% plant-based (vegan) diet
- Age 18-40
Exclusion Criteria:
- History of smoking within 2 years or being a current smoker
- Taking vasoactive medications
- Having overt cardiovascular, metabolic, or neurological disease
- Pregnant individuals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Typical American Diet
African American individuals who self-report adhering to a typical American diet prior to enrolling in the study.
|
Participants self-reported adherence to a typical American diet prior to enrolling in the study.
This factor determined cross-sectional group allocation.
|
|
Plant-Based Diet
African American individuals who self-report adhering to a plant-based diet prior to enrolling in the study.
|
Participants self-reported adherence to a 100% plant-based diet prior to enrolling in the study.
This factor determined cross-sectional group allocation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
Time Frame: Day 1
|
Day 1
|
|
C-reactive protein
Time Frame: Day 1
|
Day 1
|
|
Post-occlusive brachial artery flow-mediated dilation (% change in brachial artery diameter from resting baseline)
Time Frame: Day 1
|
Day 1
|
|
Post-occlusive forearm reactive hyperemia (% change in brachial artery blood velocity from resting baseline)
Time Frame: Day 1
|
Day 1
|
|
Pulse wave velocity (carotid-to-femoral)
Time Frame: Day 1
|
Day 1
|
|
Augmentation index (AIx@HR75)
Time Frame: Day 1
|
Day 1
|
|
Cerebral vascular reactivity (% change in cerebrovascular conductance index from resting baseline)
Time Frame: Day 2
|
Day 2
|
|
Local cutaneous thermal hyperemia (% change in cutaneous vascular conductance from resting baseline)
Time Frame: Day 2
|
Day 2
|
|
Peripheral blood pressure (systolic, diastolic, mean)
Time Frame: Day 1
|
Day 1
|
|
Central blood pressure (systolic, diastolic, mean)
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert M Brothers, PhD, The University of Texas at Arlington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2019
Primary Completion (Actual)
January 13, 2020
Study Completion (Actual)
January 13, 2020
Study Registration Dates
First Submitted
April 12, 2022
First Submitted That Met QC Criteria
April 19, 2022
First Posted (Actual)
April 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data Availability Statement: All raw data were collected and generated at the University of Texas at Arlington.
Data supporting the findings and conclusions of this study are available from the corresponding author upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.