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ICR + Time-Restricted Eating for Coronary Artery Disease (TRE x ICR Trial)

N/A

Waitlist Available

Led By Pam R Taub, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program

If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs, no dose adjustments will be allowed during the study period.

Must not have

Systolic HF alone

History of adrenal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 1-9

Summary

This trial will help assess whether reducing the number of hours one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include changes in energy levels due to altered eating times which could affect metabolism and mood. There might also be initial discomfort as the body adjusts to new meal schedules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history of adrenal gland problems.

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I have had surgery to help manage my weight.

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I have been using insulin in the past 6 months.

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I have a history of cirrhosis.

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I have type 1 diabetes and need insulin.

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I have a history of HIV/AIDS.

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I have a diagnosed inflammatory or rheumatologic condition.

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I have had a heart transplant in the last year.

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I am on medication that affects my appetite.

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I have advanced chronic kidney disease or am on dialysis.

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I am currently being treated for cancer, except for non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 1-9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 1-9

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 1-9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Exercise Capacity (MetS)

Secondary study objectives

Change in LDL cholesterol

Change in Triglycerides

Change in non-HDL cholesterol

Other study objectives

Change in TMAO levels

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)Experimental Treatment1 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 Group1 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.

0 / 15Eligibility criteria met