Decoding Your Diet (DYD)

Early Phase 1

Not yet recruiting

• Conditions: Cardiovascular Disease
• Interventions: Genetic: Decoding Your Diet

• Registration Number: NCT05904639
• Lead Sponsor: Morehouse School of Medicine

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.

Study Timeline

• Study First Submitted: 2023-05-08
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-18
• Study Start: 2023-07
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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)
• Chronic fluid retention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pre-study	Decoding Your Diet	Baseline or pre-study arm
Cross-over arm	Decoding Your Diet	Intervention arm

Primary Outcome Measures

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

Trial Locations

Locations (1)

Morehouse School of Medicine; 🇺🇸 Atlanta, Georgia, United States