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Clinical Trials/NCT05904639
NCT05904639
Not yet recruiting
Early Phase 1

Multivariable Transcriptomic Analysis, Dietary Patterns and Cardiovascular Risk in African Americans

Morehouse School of Medicine1 site in 1 country15 target enrollmentJuly 2023

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
Morehouse School of Medicine
Enrollment
15
Locations
1
Primary Endpoint
Differential changes in gene expression from baseline to end of study.
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Our study will determine if a high quality AHA plant-based diet intervention can promote a genetic signature that is protective against CVD. Our development of GE mutational signatures in Blacks/African Americans with a high CVD burden can inform of changes patients can implement in their diet and lifestyle to decrease the CVD risk burden.

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide, contributing to 1 in every 4 deaths. Compared to European Americans, African Americans have higher risks for cardiometabolic conditions. Our study aim is to determine if a high-quality American Heart Association (AHA) plant-based diet intervention can promote a genetic mutational signature that is protective against CVD. We will enroll 15 Black/African American cardiac patients from Grady Memorial Hospital, Atlanta, GA. We will investigate from baseline to 3 months how the AHA plant-based diet intervention affected the regulation of several genes that are differentially expressed (DEG) and cluster together within biological pathways. We will integrate this information with WGS data, clinical factors, and ASA24-hour recalls. We expect that the AHA plant-based diet will be protective against deleterious DEG patterns that promote development of CVD. Our DEG mutational signatures in Black/African Americans with a high CVD burden can inform of changes patients can implement in their diet to decrease CVD risk burden. Our study will also fill gaps in providing new information regarding novel genomic-biological signatures with diet predictors and risk factors of CVD that can be useful in designing prevention and treatment strategies in precision medical care.

Registry
clinicaltrials.gov
Start Date
July 2023
End Date
July 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • All other racial groups
  • Age \< 40 years
  • Normal weight (BMI 18.5-24.9 kg/m2)
  • Normal waist circumference \< 40 inches (\<102 cm) for men and \< 35 inches (\<88 cm) for women
  • \< 3 abnormal metabolic traits/ diagnosed cardiometabolic diseases
  • Orthopedic conditions (i.e., recent hip or knee replacement)
  • Paralysis
  • Diagnosed severe dementia
  • End-stage renal disease: chronic kidney disease: stage 3 or 4
  • Congestive heart failure (advanced stage and not fluid-stable)

Outcomes

Primary Outcomes

Differential changes in gene expression from baseline to end of study.

Time Frame: 3 months

Differential changes in gene expression will be assessed by statistics. These changes will be assessed in response to changes in cardiovascular risk factors when the participants use an AHA plant-based diet.

Study Sites (1)

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