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Clinical Trial Summary

Time restricted eating (TRE) is a form of intermittent fasting 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 be a two site (Toronto Rehabilitation Institute and Toronto Western Hospital), 2-arm, parallel group, randomized feasibility trial of cardiac rehabilitation alone or cardiac rehabilitation plus 16:8 TRE. Men and women who are referred through the standard clinical pathways and eligible for either outpatient cardiac rehabilitation program for coronary artery disease and are willing to accept random assignment and complete the study assessments will be enrolled. Both groups will receive the standard, multi-dimensional cardiac rehabilitation program consisting of physician-directed risk factor management, an individualized exercise prescription, and virtual education. All participants will receive an assessment with a registered dietitian and individualized recommendations for a heart healthy diet. During the consultation with the registered dietitian, the TRE group participants will also be counselled to restrict their eating to between 11 am and 7 pm and consume no calories outside of those hours during the program starting the evening of the consultation. The primary outcome is feasibility measured by daily adherence to the 16-hour fast which will be tracked with two daily text messages for the 16 weeks of the cardiac rehabilitation program. The safety outcomes that will be compared between groups include re-hospitalization, death, angina, and nutritional impact symptoms. Before randomization and after completion of the program the following preliminary efficacy outcomes will be assessed: 1) VO2peak; 2) total body and truncal fat, lean mass; 3) metabolic markers: fasted glucose, insulin, hemoglobin A1c, blood pressure and waist circumference. The investigators hypothesize that cardiac rehabilitation and TRE will be feasible, safe, and provide added cardiovascular health benefits compared to cardiac rehabilitation alone.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05075317
Study type Interventional
Source University of Toronto
Contact Amy Kirkham, PhD
Phone ?(416) 946-4069?
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 1, 2021
Completion date March 31, 2023

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