Coronary Artery Disease
Conditions
Keywords
Time Restricted Eating, Circadian Rhythm, Cardiac Rehabilitation
Brief summary
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.
Interventions
BEHAVIORALICR (Intensive Cardiac Rehabilitation)
Participants in this arm will not have to adopt a 10-hour eating window while taking part in UCSD's 9-week ICR program.
BEHAVIORALICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
Participants in this arm will adhere to a daily, consistent 10-hour eating window while undergoing UCSD's 9-week ICR program to see if there is an improvement on cardiometabolic parameters.
Sponsors
Salk Institute for Biological Studies
The Cleveland Clinic
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-75 years 2. Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program 3. Established diagnosis of coronary artery disease (concomitant systolic or diastolic HF is allowable) 4. Own a smartphone (Apple iOS or Android OS) 5. 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.
Exclusion criteria
1. Taking insulin within the last 6 months. 2. Known inflammatory and/or rheumatologic disease. 3. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse. 4. Pregnant or breast-feeding women. 5. Shift workers with variable (e.g. nocturnal) hours. 6. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions. 7. Planned international travel during study period. 8. Systolic HF alone. 9. Heart transplant within the past 1 year. 10. Presence of left ventricular assist device. 11. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Capacity (MetS) | Baseline and Week 1-9 | Exercise Capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL cholesterol | Baseline and Week 9 | LDL cholesterol (mg/dL) |
| Change in non-HDL cholesterol | Baseline and Week 9 | non-HDL cholesterol (mg/dL) |
| Change in Triglycerides | Baseline and Week 9 | Triglycerides (mg/dL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in TMAO levels | Baseline and Week 9 | TMAO levels (uM) |
Countries
United States
Outcome results
None listed