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| Name | Class |
|---|---|
| Salk Institute for Biological Studies | OTHER |
| The Cleveland Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICR (Intensive Cardiac Rehabilitation) | Placebo Comparator | 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. |
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| ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICR (Intensive Cardiac Rehabilitation) | Behavioral | Participants in this arm will not have to adopt a 10-hour eating window while taking part in UCSD's 9-week ICR program. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Capacity (MetS) | Exercise Capacity | Baseline and Week 1-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL cholesterol | LDL cholesterol (mg/dL) | Baseline and Week 9 |
| Change in non-HDL cholesterol | non-HDL cholesterol (mg/dL) | Baseline and Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TMAO levels | TMAO levels (uM) | Baseline and Week 9 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pam R Taub, MD | UC San Diego Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | La Jolla | California | 92093 | United States |
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| ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) | Behavioral | 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. |
|
| Change in Triglycerides | Triglycerides (mg/dL) | Baseline and Week 9 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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