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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05344287
Other study ID # 2019-0318
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 12, 2019
Est. completion date January 13, 2020

Study information

Verified date April 2022
Source The University of Texas at Arlington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date January 13, 2020
Est. primary completion date January 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Typical American Diet
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
Participants self-reported adherence to a 100% plant-based diet prior to enrolling in the study. This factor determined cross-sectional group allocation.

Locations

Country Name City State
United States UT Arlington - Science and Engineering Innovation and Research Building Arlington Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG) Day 1
Primary C-reactive protein Day 1
Primary Post-occlusive brachial artery flow-mediated dilation (% change in brachial artery diameter from resting baseline) Day 1
Primary Post-occlusive forearm reactive hyperemia (% change in brachial artery blood velocity from resting baseline) Day 1
Primary Pulse wave velocity (carotid-to-femoral) Day 1
Primary Augmentation index (AIx@HR75) Day 1
Primary Cerebral vascular reactivity (% change in cerebrovascular conductance index from resting baseline) Day 2
Primary Local cutaneous thermal hyperemia (% change in cutaneous vascular conductance from resting baseline) Day 2
Primary Peripheral blood pressure (systolic, diastolic, mean) Day 1
Primary Central blood pressure (systolic, diastolic, mean) Day 1
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