Decoding Your Diet (DYD)

Cardiovascular Disease Clinical Trial

— DYD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05904639
• Other study ID #: 1992237-3
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2023
• Est. completion date: July 2024

Study information

• Verified date: June 2023
• Source: Morehouse School of Medicine
• Contact: Dale S Hardy
• Phone: 404-756-1346
• Email: dhardy[@]msm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Morehouse School of Medicine	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Morehouse School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential changes in gene expression from baseline to end of study.	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.	3 months