Time-restricted eating combined with cardiac rehabilitation for heart disease
Time Restricted Eating and Cardiac Rehabilitation
This study is testing if combining time-restricted eating with cardiac rehab can help people with heart disease improve their fitness and lose fat better than rehab alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05075317 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of a nutrition intervention called time-restricted eating (TRE) in conjunction with standard cardiac rehabilitation for patients with coronary artery disease. Participants will follow an 8-hour eating window each day, allowing for a 16-hour fasting period, to assess adherence and potential cardiovascular health benefits. The study aims to determine if TRE can enhance the outcomes of cardiac rehabilitation by improving cardiorespiratory fitness and reducing fat mass compared to rehabilitation alone.
Who should consider this trial
Good fit: Ideal candidates include men and women eligible for outpatient cardiac rehabilitation for coronary artery disease or peripheral vascular disease.
Not a fit: Patients with a history of eating disorders, type 1 diabetes, or those unable to adhere to the study's dietary requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cardiovascular health and rehabilitation outcomes for patients with coronary artery disease.
How similar studies have performed: While time-restricted eating has shown benefits in other populations, this specific application in cardiac rehabilitation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women who are referred and eligible for either the outpatient cardiac rehabilitation program for coronary artery disease or peripheral vascular disease * willing to accept random assignment and complete the study assessments * Equal numbers of men and women will be recruited Exclusion Criteria: * Inability to complete the consent form and communicate in English * Self-reported history of an eating disorder * Current or recent (1 year) pregnancy or breast feeding * Body mass index \<18.5 kg/m\^2 or clinical signs of cachexia * Contraindications or inability to perform cardiopulmonary exercise testing * Type 1 diabetes * Type 2 diabetes that requires exogenous insulin * Working night or rotating shifts * Eating window \<12 hours or consistently eating less than 3 meals/day in the past 3 months
Where this trial is running
Toronto, Ontario
- Toronto Rehabilitation Institute, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Amy Kirkham, PhD — University of Toronto, KITE Research Institute
- Study coordinator: Amy Kirkham, PhD
- Email: amy.kirkham@utoronto.ca
- Phone: (416) 946-4069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.