Decoding Your Diet (DYD) (DYD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Genetic: Decoding Your Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Dale S Hardy; Phone Number: 404-756-1346; Email: dhardy@msm.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
      • Contact: Dale Hardy, PhD; Phone Number: 404-756-1346; Email: dhardy@msm.edu
      • Contact: Tennille Leak-Johnson, PhD; Phone Number: 404-756-5225; Email: tleakjohnson@msm.edu
      • Sub-Investigator: Kisha Holden, PhD
      • Sub-Investigator: Tennille Leak-johnson, PhD
      • Sub-Investigator: Fengxia Yan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Black or African American
• Age ≥ 40 years
• All sexes as determine by biology (sex chromosomes)
• ≥3 abnormal metabolic traits including diagnosed cardiometabolic diseases:
• At least Class I Obesity (BMI ≥ 30 kg/m2)
• High waist circumference: > 40 inches (102 cm) for men and > 35 inches (88 cm) for women
• Diagnosed cardiometabolic diseases or metabolic traits:
• diagnosed heart disease, stroke
• Peripheral vascular disease, carotid artery disease, type 2 diabetes without disability
• HbA1c > 6.4%, or fasting: >126 mg/dL or postprandial > 200 mg/dL or OGTT > 200 mg/dL
• ≥ grade 1 hypertension: SBP >140mmHg or dbp: > 90mmHg
• Triglycerides > 150mg/Dl
• Total cholesterol > 200 mg/dL
• HDL cholesterol <40 mg/dL for men or < 50 mg/dL for women
• LDL > 160 mg/dL; VLDL > 30 mg/dL

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)
• Chronic fluid retention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-study; Baseline or pre-study arm	Genetic: Decoding Your Diet; We will collect information from cardiac patients on their genes at baseline and then expose them to a diet intervention and collect genetic information after the intervention.
Experimental: Cross-over arm; Intervention arm	Genetic: Decoding Your Diet; We will collect information from cardiac patients on their genes at baseline and then expose them to a diet intervention and collect genetic information after the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential changes in gene expression from baseline to end of study.	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.	3 months

Collaborators and Investigators

• Sponsor: Morehouse School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: diet; cardiovascular; gene expression; transcriptomics
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1992237-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No