Cardiovascular DiseasesNCT05344287
Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans
An observational study of Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Diet, Healthy
- What is being tested?
- Typical American Diet and Plant-Based Diet
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 13 Jan 2020
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample from the greater Dallas-Fort Worth Metroplex area.
Who may be able to join
- 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
Who cannot join
- History of smoking within 2 years or being a current smoker
- Taking vasoactive medications
- Having overt cardiovascular, metabolic, or neurological disease
- Pregnant individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, 76019
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases, Hypertension, Diet, Healthy
- Being tested
- Typical American Diet, Plant-Based Diet
- Keywords
- health disparity, endothelial function, hypertension, vegan diet, Black Americans, inflammation
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typical American DietOther
Participants self-reported adherence to a typical American diet prior to enrolling in the study. This factor determined cross-sectional group allocation.
Plant-Based DietOther
Participants self-reported adherence to a 100% plant-based diet prior to enrolling in the study. This factor determined cross-sectional group allocation.
| Study group | Role | What they receive |
|---|---|---|
| Typical American Diet | African American individuals who self-report adhering to a typical American diet prior to enrolling in the study. Receives: Other: Typical American Diet | |
| Plant-Based Diet | African American individuals who self-report adhering to a plant-based diet prior to enrolling in the study. Receives: Other: Plant-Based Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
Measured: Day 1
C-reactive protein
Measured: Day 1
Post-occlusive brachial artery flow-mediated dilation (% change in brachial artery diameter from resting baseline)
Measured: Day 1
Post-occlusive forearm reactive hyperemia (% change in brachial artery blood velocity from resting baseline)
Measured: Day 1
Pulse wave velocity (carotid-to-femoral)
Measured: Day 1
Augmentation index (AIx@HR75)
Measured: Day 1
Cerebral vascular reactivity (% change in cerebrovascular conductance index from resting baseline)
Measured: Day 2
Local cutaneous thermal hyperemia (% change in cutaneous vascular conductance from resting baseline)
Measured: Day 2
Peripheral blood pressure (systolic, diastolic, mean)
Measured: Day 1
Central blood pressure (systolic, diastolic, mean)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start12 Jul 2019
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
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 Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brothers, The University of Texas at Arlington
- Investigators
- Robert M Brothers, PhD, Principal investigator, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344287
- Sponsor's protocol ID
- 2019-0318
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Martin ZT, Olvera G, Villegas CA, Campbell JC, Akins JD, Brown KK, Brothers RM. The impact of a plant-based diet on indices of cardiovascular health in African Americans: a cross-sectional study. Appl Physiol Nutr Metab. 2022 Sep 1;47(9):903-914. doi: 10.1139/apnm-2022-0027. Epub 2022 May 5.
PubMed 35512369
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05344287
- Acronym / sponsor ID
- 2019-0318
- Conditions
- Cardiovascular Diseases, Hypertension, Diet, Healthy
- Keywords
- health disparity, endothelial function, hypertension, vegan diet, Black Americans, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 25 Apr 2022 (actual)
- 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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical American Diet | – | Other: Typical American DietAfrican American individuals who self-report adhering to a typical American diet prior to enrolling in the study. |
| Plant-Based Diet | – | Other: Plant-Based DietAfrican American individuals who self-report adhering to a plant-based diet prior to enrolling in the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample from the greater Dallas-Fort Worth Metroplex area.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- History of smoking within 2 years or being a current smoker
- Taking vasoactive medications
- Having overt cardiovascular, metabolic, or neurological disease
- Pregnant individuals
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 |
|---|---|---|
| Typical American DietParticipants self-reported adherence to a typical American diet prior to enrolling in the study. This factor determined cross-sectional group allocation. | Other | Typical American Diet |
| Plant-Based DietParticipants self-reported adherence to a 100% plant-based diet prior to enrolling in the study. This factor determined cross-sectional group allocation. | Other | Plant-Based Diet |
Primary outcome
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
Time frame: Day 1
C-reactive protein
Time frame: Day 1
Post-occlusive brachial artery flow-mediated dilation (% change in brachial artery diameter from resting baseline)
Time frame: Day 1
Post-occlusive forearm reactive hyperemia (% change in brachial artery blood velocity from resting baseline)
Time frame: Day 1
Pulse wave velocity (carotid-to-femoral)
Time frame: Day 1
Augmentation index (AIx@HR75)
Time frame: Day 1
Cerebral vascular reactivity (% change in cerebrovascular conductance index from resting baseline)
Time frame: Day 2
Local cutaneous thermal hyperemia (% change in cutaneous vascular conductance from resting baseline)
Time frame: Day 2
Peripheral blood pressure (systolic, diastolic, mean)
Time frame: Day 1
Central blood pressure (systolic, diastolic, mean)
Time frame: Day 1
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 5 May 2022.
- Derived from this study: PubMed 35512369Martin ZT, Olvera G, Villegas CA, Campbell JC, Akins JD, Brown KK, Brothers RM. The impact of a plant-based diet on indices of cardiovascular health in African Americans: a cross-sectional study. Appl Physiol Nutr Metab. 2022 Sep 1;47(9):903-914. doi: 10.1139/apnm-2022-0027. Epub 2022 May 5.
- Individual participant dataSharing planned: Yes. 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.
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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.
Robert M Brothers, PhD principal investigator
The University of Texas at Arlington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington 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 3 inclusion and 4 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 5 May 2022. 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?
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG) (time frame: Day 1). The study lists 10 primary outcomes in all. 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 NCT05344287, 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 5 May 2022.