Cardiovascular DiseaseEarly Phase 1DYDNCT05904639
Decoding Your Diet (DYD)
A Early Phase 1 study testing Decoding Your Diet in people with Cardiovascular Disease, run by Morehouse School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Decoding Your Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2023to Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Morehouse School of Medicine
Atlanta, Georgia, 30310
Dale Hardy, PhD, 404-756-1346, dhardy@msm.edu
Tennille Leak-Johnson, PhD, 404-756-5225, tleakjohnson@msm.edu
About this study
Official title: Multivariable Transcriptomic Analysis, Dietary Patterns and Cardiovascular Risk in African Americans
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Decoding Your Diet
- Keywords
- diet, transcriptomics, gene expression, cardiovascular
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decoding Your DietGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-study | Experimental | Baseline or pre-study arm Receives: Genetic: Decoding Your Diet |
| Cross-over arm | Experimental | Intervention arm Receives: Genetic: Decoding Your Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904639
- Sponsor's protocol ID
- 1992237-3
- Acronym
- DYD
- Status last verified
- Jun 2023
- First submitted
- 8 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariable Transcriptomic Analysis, Dietary Patterns and Cardiovascular Risk in African Americans
- ClinicalTrials.gov ID
- NCT05904639
- Acronym / sponsor ID
- DYD / 1992237-3
- Conditions
- Cardiovascular Disease
- Keywords
- diet, transcriptomics, gene expression, cardiovascular
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-study | Experimental | Genetic: Decoding Your DietBaseline or pre-study arm |
| Cross-over arm | Experimental | Genetic: Decoding Your DietIntervention arm |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decoding Your DietWe 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. | Genetic | Cross-over arm, Pre-study |
Primary outcome
Differential changes in gene expression from baseline to end of study.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Decoding Your Diet in people with Cardiovascular Disease, run by Morehouse School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dale S Hardy (404-756-1346, dhardy@msm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential changes in gene expression from baseline to end of study. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.