Clinical trial NCT05904639: Decoding Your Diet (DYD)
Official title: Multivariable Transcriptomic Analysis, Dietary Patterns and Cardiovascular Risk in African Americans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cardiovascular Disease
Keywords: diet
transcriptomics
gene expression
cardiovascular
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In this study, we will implement a high quality AHA plant-based diet intervention on cardiac patients and study its effects on GE. We will use a GE-whole genome sequencing (WGS) cluster approach in which we will integrate genetic-biological technologies within pathways associated with CVD to create risk score clusters. We will develop risk scores and identify top (most significant by p value) genetic clusters in common functional pathways. We will further integrate genetic information with clinical factors and CVD risk factors and investigate association with AHA diet.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Differential changes in gene expression from baseline to end of study.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
Study officials:
References: