Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation
NCT ID: NCT05014880
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
28 participants
INTERVENTIONAL
2021-09-02
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICR (Intensive Cardiac Rehabilitation)
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.
ICR (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.
ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
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.
ICR 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.
Interventions
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ICR (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.
ICR 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
12. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
13. History of adrenal disease.
14. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
15. History of type I diabetes with ongoing insulin dependence.
16. History of eating disorders.
17. History of cirrhosis.
18. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
19. History of HIV/AIDS.
20. Currently enrolled in a weight-loss or weight-management program. This does not include UC San Diego's Cardiac Rehabilitation Programs.
21. On a special or prescribed diet for other reasons (e.g. Celiac disease).
22. Currently taking any medication that is meant for, or has a known effect on, appetite.
23. Any history of surgical intervention for weight management.
24. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
25. Baseline eating window \<14 hours per day as documented on mCC app.
26. Failure to use the smartphone app for documentation (defined as \<2 meals/day for ≥3 days during baseline).
18 Years
75 Years
ALL
No
Sponsors
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Salk Institute for Biological Studies
OTHER
The Cleveland Clinic
OTHER
University of California, San Diego
OTHER
Responsible Party
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Pam Taub, MD
Professor of Medicine
Principal Investigators
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Pam R Taub, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego Health
Locations
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Altman Clinical and Translational Research Institute
La Jolla, California, United States
Countries
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Other Identifiers
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200530
Identifier Type: -
Identifier Source: org_study_id
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