Coronary Artery Disease Clinical Trial
— TREat-CROfficial title:
Time Restricted Eating and Cardiac Rehabilitation
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women who are referred and eligible for either the outpatient cardiac rehabilitation program for coronary artery 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Rehabilitation Institute, University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Macronutrient ratios | 3-day food record analysed by food analysis software to estimate macronutrient intake | 16 weeks | |
Other | Caloric intake | 3-day food record analysed by food analysis software to estimate intake | 16 weeks | |
Other | Cardiac rehabilitation adherence | The participant's clinical chart for the cardiac rehabilitation program will be reviewed to extract adherence data to the standard components of the program (exercise, nutrition, education, social worker) | 16 weeks | |
Other | Time-restricted eating experience | At the end of the intervention, the TRE group will complete a researcher developed questionnaire that asks questions about acceptability of TRE and confidence in continuing the intervention long-term | 16 weeks | |
Other | Mediterranean Diet Score | Standard scoring of 14-item Mediterranean Diet Score Tool (minimum = 0, maximum = 14, higher score indicates better outcome) | 16 weeks | |
Other | Physical activity and sedentary time | Participants will wear an accelerometer device for 5 days with 3 full days used for analysis | 16 weeks | |
Primary | Adherence to the daily =16-hour fast for the 16-weeks of the cardiac rehabilitation program. | Assessed daily through a custom twice daily automated text message (or email) program, or written logs for those without cell phones. Adherence will be measured as a % of days with =16-hour fast. | Averaged over the 16 weeks of the intervention | |
Primary | Cardiorespiratory fitness as measured by peak volume of oxygen consumption (VO2peak) | Assessed by an incremental, to-maximum cardiopulmonary treadmill exercise test. | 16 weeks | |
Primary | Fat mass | Assessed by dual absorptiometry x-ray (DXA) scan. | 16 weeks | |
Secondary | Symptoms from TRE | Self-report of various nutritional impact adverse events collected at support phone calls for both groups | 16 weeks | |
Secondary | Seattle Angina Questionnaire score | Standard scoring of Seattle Angina Questionnaire (minimum = 0, maximum = 100, higher score means better outcome) | 16 weeks | |
Secondary | Adverse events | re-hospitalizations, recurrent cardiac events, death extracted from medical records | 1-year | |
Secondary | Fat-free mass | Assessed by dual absorptiometry x-ray (DXA) scan. | 16 weeks | |
Secondary | Hemoglobin A1c | Measured by blood draw | 16 weeks | |
Secondary | Blood pressure | Systolic and diastolic blood pressure will manually assessed as the average of the 2nd to 6th measurements | 16 weeks | |
Secondary | Waist circumference | Measured by an inelastic tape at the level of the top of iliac crest as the average of two measurements | 16 weeks | |
Secondary | Fasted blood glucose | Measured by fasted blood draw | 16 weeks | |
Secondary | Metabolic syndrome | As defined by the NCEP/ATP III criteria | 16 weeks | |
Secondary | Lipid profile | Individual measures and ratios of total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides from fasted blood draw | 16 weeks | |
Secondary | Health-related quality of life measured by the RAND-36 Physical Component Summary | Physical component summary of the RAND-36 questionnaire (minimum = 0, maximum = 50, higher score is better outcome) | 16 weeks |
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