Clinical trial NCT05344287: Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans
Official title: The Impact of a Plant-Based Diet on Indices of Cardiovascular Health in African Americans: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hypertension
Diet, Healthy
Keywords: health disparity
endothelial function
hypertension
vegan diet
Black Americans
inflammation
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample from the greater Dallas-Fort Worth Metroplex area.

Brief 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 function, and blood lipid profiles, along with lower systemic inflammation relative to African Americans following a typical American diet.


Eligibility criteria: 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

Primary outcomes:
measure: Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
timeFrame: Day 1
measure: C-reactive protein
timeFrame: Day 1
measure: Post-occlusive brachial artery flow-mediated dilation (% change in brachial artery diameter from resting baseline)
timeFrame: Day 1
measure: Post-occlusive forearm reactive hyperemia (% change in brachial artery blood velocity from resting baseline)
timeFrame: Day 1
measure: Pulse wave velocity (carotid-to-femoral)
timeFrame: Day 1
measure: Augmentation index (AIx@HR75)
timeFrame: Day 1
measure: Cerebral vascular reactivity (% change in cerebrovascular conductance index from resting baseline)
timeFrame: Day 2
measure: Local cutaneous thermal hyperemia (% change in cutaneous vascular conductance from resting baseline)
timeFrame: Day 2
measure: Peripheral blood pressure (systolic, diastolic, mean)
timeFrame: Day 1
measure: Central blood pressure (systolic, diastolic, mean)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: UT Arlington - Science and Engineering Innovation and Research Building
state: Texas
Study officials:
affiliation: The University of Texas at Arlington
name: Robert M Brothers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.