Decoding Your Diet (DYD)

Sponsor

Morehouse School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05904639

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Genetic: Decoding Your Diet	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Single (Participant)

Masking Description:

masking of participants to biostatistician.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Morehouse School of Medicine	Atlanta	Georgia	United States	30310

Sponsors and Collaborators

Morehouse School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morehouse School of Medicine

ClinicalTrials.gov Identifier:

NCT05904639

Other Study ID Numbers:

1992237-3

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Morehouse School of Medicine

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Jun 18, 2023