Decoding Your Diet (DYD)

NCT ID: NCT05904639

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-07-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pre-study

Baseline or pre-study arm

Group Type: EXPERIMENTAL

Decoding Your Diet

Intervention Type: GENETIC

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.

Cross-over arm

Intervention arm

Group Type: EXPERIMENTAL

Decoding Your Diet

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Morehouse School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Morehouse School of Medicine

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Dale S Hardy

Role: CONTACT

dhardy@msm.edu

404-756-1346

Facility Contacts

Dale Hardy, PhD

Role: primary

dhardy@msm.edu

404-756-1346

Tennille Leak-Johnson, PhD

Role: backup

tleakjohnson@msm.edu

404-756-5225

Other Identifiers

1992237-3

Identifier Type: -

Identifier Source: org_study_id