Decoding Your Diet (DYD)

NCT05904639 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: 1992237-3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

diet; transcriptomics; gene expression; cardiovascular

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pre-study

EXPERIMENTAL

Baseline or pre-study arm

Genetic: Decoding Your Diet

Cross-over arm

EXPERIMENTAL

Intervention arm

Genetic: Decoding Your Diet

Interventions

Decoding Your Diet 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; Pre-study

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morehouse School of Medicine: lead

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Dale S Hardy

CONTACT

404-756-1346; dhardy@msm.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: masking of participants to biostatistician.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)