ICR + Time-Restricted Eating for Coronary Artery Disease

(TRE x ICR Trial)

Overseen By Victoria A Green, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Insulin, Appetite medications

Disqualifiers: Inflammatory disease, Tobacco use, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if reducing the number of hours during which one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health (i.e. blood sugar levels and blood pressure). The study also aims to assess changes in exercise capacity and trimethylamine N-oxide (TMAO) levels in response to Time Restricted Eating (TRE) and Intensive Cardiac Rehabilitation (ICR) versus ICR alone. TMAO is a metabolite, or a substance, produced during digestion and metabolism. Preliminary data illustrates a correlation between high levels of TMAO and higher risk of cardiovascular disease and mortality. We will also be looking at participants' long-term cardiovascular health status after they complete the ICR program.

Research Team

Pam R Taub, MD

Principal Investigator

UC San Diego Health

Eligibility Criteria

This trial is for adults aged 18-75 with coronary artery disease who are enrolled in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program. Participants must be on stable doses of cardiovascular medications, own a smartphone, and not have conditions like active cancer (except non-melanoma skin cancer), inflammatory diseases, type I diabetes requiring insulin, or severe kidney disease.

Inclusion Criteria

Own a smartphone (Apple iOS or Android OS)

I am on heart or diabetes medication and cannot change the dose during the study.

I am enrolled in UC San Diego's 9-week heart rehab program.

Exclusion Criteria

I have heart failure that affects the heart's pumping ability.

You have a device supporting the left side of your heart.

I am currently in a weight-loss or management program, not including UC San Diego's Cardiac Rehab.

Treatment Details

Interventions

• Intensive Cardiac Rehabilitation
• Time Restricted Eating

Trial Overview The study tests if Time-Restricted Eating (TRE) combined with Intensive Cardiac Rehabilitation (ICR) can improve cholesterol levels, blood sugar, blood pressure, exercise capacity and reduce TMAO levels compared to just ICR. TRE involves eating within a certain number of hours each day.

Participant Groups

Group I: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) Experimental Treatment 1 Intervention

20 patients will be randomly assigned to the Time-Restricted Eating (TRE) group which will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR x TRE" group.

Group II: ICR (Intensive Cardiac Rehabilitation) Placebo Group 1 Intervention

20 patients will be randomly assigned to the standard of care group, which will receive the standard health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR" group.

Intensive Cardiac Rehabilitation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Intensive Cardiac Rehabilitation for:

• Acute myocardial infarction
• Coronary bypass surgery
• Stable angina pectoris
• Heart valve repair or replacement
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
• Heart or heart-lung transplant

Approved in European Union as Intensive Cardiac Rehabilitation for:

• Myocardial infarction
• Coronary artery bypass grafting
• Stable angina
• Heart failure
• Valvular surgery
• Cardiac transplantation

Approved in Canada as Intensive Cardiac Rehabilitation for:

• Recent myocardial infarction
• Acute coronary artery syndrome
• Chronic stable angina
• Congestive heart failure
• After coronary artery bypass surgery
• After a percutaneous coronary intervention
• Valvular surgery
• Cardiac transplantation

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+