Decoding Your Diet (DYD) | NCT05904639

Studies
Decoding Your Diet (DYD)

NCT05904639

Sponsor

Morehouse School of Medicine

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

15Estimated

Phase

Early Phase 1

Conditions

Cardiovascular Disease

Interventions

Decoding Your Diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2023Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

May 8, 2023

First Submission Date that Met QC Criteria

Jun 12, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre-study	Experimental	Baseline or pre-study arm	Genetic: Decoding Your Diet
Cross-over arm	Experimental	Intervention arm	Genetic: Decoding Your Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Dale S Hardy	Contact	404-756-1346		dhardy@msm.edu

Facility	Status	City	State	ZIP	Country	Contacts
Morehouse School of Medicine		Atlanta	Georgia	30310	United States

ID	Term
D002318	Cardiovascular Diseases

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.