NCT05075317 Time Restricted Eating and Cardiac Rehabilitation
| NCT ID | NCT05075317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Toronto |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-07-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will use a form of intermittent fasting called time-restricted eating (TRE) where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE could be an effective addition to cardiac rehabilitation as it has demonstrated cardiovascular health benefits and potential for synergy when combined with exercise training. This study will determine if TRE is a feasible and safe nutrition intervention during cardiac rehabilitation and if TRE improves the health benefits of cardiac rehabilitation compared to cardiac rehabilitation alone.
Eligibility 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
Contact & Investigator
Paul Oh, MD
STUDY DIRECTOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05075317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05075317 currently recruiting?
Yes, NCT05075317 is actively recruiting participants. Contact the research team at amy.kirkham@utoronto.ca for enrollment information.
Where is the NCT05075317 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05075317 clinical trial?
NCT05075317 is sponsored by University of Toronto. The principal investigator is Paul Oh, MD at University Health Network, Toronto. The trial plans to enroll 60 participants.