Decoding Your Diet (DYD)

Morehouse School of Medicine

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Cardiovascular Disease

Treatments: Genetic: Decoding Your Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05904639

1992237-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Pre-study

Experimental group

Description:

Baseline or pre-study arm

Treatment:

Genetic: Decoding Your Diet

Cross-over arm

Experimental group

Description:

Intervention arm

Treatment:

Genetic: Decoding Your Diet