Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT05014880
- Lead Sponsor
- University of California, San Diego
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age: 18-75 years<br><br> 2. Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac<br> Rehabilitation Program<br><br> 3. Established diagnosis of coronary artery disease (concomitant systolic or diastolic<br> HF is allowable)<br><br> 4. Own a smartphone (Apple iOS or Android OS)<br><br> 5. If patients are on cardiovascular medications (HMG CoA reductase inhibitors<br> (statins), other lipid modifying drugs (including over the counter drugs such as red<br> yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs, no dose<br> adjustments will be allowed during the study period.<br><br>Exclusion Criteria:<br><br> 1. Taking insulin within the last 6 months.<br><br> 2. Known inflammatory and/or rheumatologic disease.<br><br> 3. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.<br><br> 4. Pregnant or breast-feeding women.<br><br> 5. Shift workers with variable (e.g. nocturnal) hours.<br><br> 6. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.<br><br> 7. Planned international travel during study period.<br><br> 8. Systolic HF alone.<br><br> 9. Heart transplant within the past 1 year.<br><br> 10. Presence of left ventricular assist device.<br><br> 11. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are<br> not exclusion criteria).<br><br> 12. History of thyroid disease requiring dose titration of thyroid replacement<br> medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of<br> thyroid replacement therapy is not an exclusion).<br><br> 13. History of adrenal disease.<br><br> 14. History of malignancy undergoing active treatment, except non-melanoma skin cancer.<br><br> 15. History of type I diabetes with ongoing insulin dependence.<br><br> 16. History of eating disorders.<br><br> 17. History of cirrhosis.<br><br> 18. History of stage 4 or 5 chronic kidney disease or requiring dialysis.<br><br> 19. History of HIV/AIDS.<br><br> 20. Currently enrolled in a weight-loss or weight-management program. This does not<br> include UC San Diego's Cardiac Rehabilitation Programs.<br><br> 21. On a special or prescribed diet for other reasons (e.g. Celiac disease).<br><br> 22. Currently taking any medication that is meant for, or has a known effect on,<br> appetite.<br><br> 23. Any history of surgical intervention for weight management.<br><br> 24. Uncontrolled psychiatric disorder (including history of hospitalization for<br> psychiatric illness).<br><br> 25. Baseline eating window <14 hours per day as documented on mCC app.<br><br> 26. Failure to use the smartphone app for documentation (defined as <2 meals/day for =3<br> days during baseline).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Exercise Capacity (MetS)
- Secondary Outcome Measures
Name Time Method Change in LDL cholesterol;Change in non-HDL cholesterol;Change in Triglycerides