Coronary Artery DiseaseTREat-CRNCT05075317
Time Restricted Eating and Cardiac Rehabilitation
A study testing Standard cardiac rehabilitation and Time-Restricted Eating in people with Coronary Artery Disease, run by University of Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Standard cardiac rehabilitation and Time-Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jul 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute, University Health Network
Toronto, Ontario, M4G 1R7
About this study
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.
Read the detailed description
HYPOTHESIS
- Cardiac rehabilitation and TRE will be feasible in terms of adherence to a 16-hour daily fast (≥70%, which would represent 5/7 days/week) and safe (no excess symptoms or adverse events)
- Cardiac rehabilitation and TRE will provide added cardiovascular health benefits (improved VO2peak, reduced fat mass) compared to cardiac rehabilitation alone.
JUSTIFICATION: Past animal and human clinical trials have demonstrated TRE to be beneficial in realigning circadian rhythm, improve coronary artery disease (CAD) and peripheral artery disease (PAD) through the reduction in calorie intake, and promote cell signalling and repair pathways during the fasting period. TRE has not been tested in patients with CAD or other heart diseases but has shown to improve comorbid conditions (diabetes and hypertension) and improve metabolic profiles (blood pressure, hemoglobin A1c, fasting glucose, insulin sensitivity, and lipid profiles. Additionally, TRE when combined with exercise, such as in cardiac rehabilitation programs, improves VO2 peak and reduces fat mass compared to exercise alone. The proposed study will deliver a TRE intervention in combination with the cardiac rehabilitation program and is expected to be feasible, safe, and improve outcomes of cardiac rehabilitation.
OBJECTIVES: The primary aim of this study is to evaluate the feasibility (adherence) and safety (adverse events) of TRE in combination with cardiac rehabilitation.
The secondary aim is to assess the efficacy of the intervention on:
- VO2peak, body composition, fasted glucose, hemoglobin A1c, blood pressure and waist circumference
- Lifestyle behavioral change outcomes (dietary intake, dietary quality, physical activity, perceived stress)
4.Cardiac rehabilitation adherence
Exploratory aims of the study include identifying sex differences (equal recruitment of males and females) and participants' experience with TRE (including confidence in maintaining this eating pattern or modifications to increase adherence).
RESEARCH METHOD 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 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. Participants randomized to the TRE group will be asked to eat only between 11 am and 7 pm for the duration of the cardiac rehabilitation program (~16 weeks). Adherence will be collected via twice daily text messages asking participants to respond with the time they started and stopped eating. Safety will be collected by self-report and medical records. Efficacy outcomes will be assessed by cardiopulmonary exercise test, blood draw, dual x-ray absorptiometry, 3-day diet records, accelerometers, and questionnaires. Study outcomes will be measured at baseline and at the end of the cardiac rehabilitation program.
SAMPLE SIZE A priori sample size for recruitment (n=60, 30 per group, equal recruitment of sex) was not fully achieved within the study period. Over the course of two years, the study efforts successfully recruited 30 male participants within the first 12 months of recruitment. Only 15 female participants were recruited after 2 years of recruitment efforts. The lower enrollment rate of females reflects both time limitations on the recruitment window and less females attending cardiac rehabilitation within the study criteria. The study team decided to end recruitment at n=45 (30 males, 15 females) after 2 years of recruitment due to personnel limitations
STATISTICAL ANALYSIS Participant characteristics will be summarized using descriptive statistics. For adherence, both the text message response rate and adherence rate to the 16-hour daily fast will be reported. The change in caloric intake, diet quality, physical activity and efficacy outcomes will be compared between groups by analysis of covariance with baseline values as covariates. Relative risk will be used to compare the incidence of safety outcomes between groups. The primary analysis will be intention to treat and performed with both sexes combined. Secondary analyses will be performed separately in each sex.
- Conditions
- Coronary Artery Disease
- Being tested
- Standard cardiac rehabilitation, Time-Restricted Eating
- Keywords
- Time-Restricted Eating, Cardiac Rehabilitation, Cardiorespiratory Fitness, Caloric Restriction, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cardiac rehabilitationBehavioural
Standard, multi-dimensional cardiac rehabilitation program.
Time-Restricted EatingBehavioural
Counselling to restrict their eating to between 11 am and 7 pm and to consume water-only for the remaining 16 hours per day
| Study group | Role | What they receive |
|---|---|---|
| Standard cardiac rehabilitation | Active comparator | The 16-week program consists of physician-directed risk factor management, an individualized aerobic and resistance exercise prescription, and virtual education on disease management and lifestyle behaviors (including exercise safety, stress management, and heart-healthy nutrition), and an assessment with a registered dietitian and individualized recommendations for a heart-healthy diet. Additionally, selected patients with identified issues such as depression, anxiety, trouble sleeping, anger and social and emotional issues will receive one-on-one counselling with a psychologist or social worker. Receives: Behavioral: Standard cardiac rehabilitation |
| Standard cardiac rehabilitation + TRE | Experimental | Participants in this group will receive the same standard assessment and individualized recommendations as the comparator group, but will also be counselled to restrict their eating to between 11 am and 7 pm during the program starting the evening of the consultation. They will also be advised to perform their home-based exercise sessions during the fasting period in the morning. Receives: Behavioral: Standard cardiac rehabilitation; Behavioral: Time-Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Averaged over the 16 weeks of the intervention
Cardiorespiratory fitness as measured by peak volume of oxygen consumption (VO2peak)
Assessed by an incremental, to-maximum cardiopulmonary treadmill exercise test.
Measured: 16 weeks
Fat mass
Assessed by dual absorptiometry x-ray (DXA) scan.
Measured: 16 weeks
Secondary outcomes (11)
Symptoms from TRE
Self-report of various nutritional impact adverse events collected at support phone calls for both groups
Measured: 16 weeks
Seattle Angina Questionnaire score
Standard scoring of Seattle Angina Questionnaire (minimum = 0, maximum = 100, higher score means better outcome)
Measured: 16 weeks
Adverse events
re-hospitalizations, recurrent cardiac events, death extracted from medical records
Measured: 1-year
Fat-free mass
Assessed by dual absorptiometry x-ray (DXA) scan.
Measured: 16 weeks
Hemoglobin A1c
Measured by blood draw
Measured: 16 weeks
Blood pressure
Systolic and diastolic blood pressure will manually assessed as the average of the 2nd to 6th measurements
Measured: 16 weeks
Waist circumference
Measured by an inelastic tape at the level of the top of iliac crest as the average of two measurements
Measured: 16 weeks
Fasted blood glucose
Measured by fasted blood draw
Measured: 16 weeks
Metabolic syndrome
As defined by the NCEP/ATP III criteria
Measured: 16 weeks
Lipid profile
Individual measures and ratios of total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides from fasted blood draw
Measured: 16 weeks
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)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start11 Jul 2022
- Primary completion31 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
- Investigators
- Paul Oh, MD, Study director, University Health Network, TorontoAmy Kirkham, PhD, Principal investigator, University of Toronto, KITE Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075317
- Sponsor's protocol ID
- REB #21-5510
- Acronym
- TREat-CR
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating and Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05075317
- Acronym / sponsor ID
- TREat-CR / REB #21-5510
- Conditions
- Coronary Artery Disease
- Keywords
- Time-Restricted Eating, Cardiac Rehabilitation, Cardiorespiratory Fitness, Caloric Restriction, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HYPOTHESIS
- Cardiac rehabilitation and TRE will be feasible in terms of adherence to a 16-hour daily fast (≥70%, which would represent 5/7 days/week) and safe (no excess symptoms or adverse events)
- Cardiac rehabilitation and TRE will provide added cardiovascular health benefits (improved VO2peak, reduced fat mass) compared to cardiac rehabilitation alone.
JUSTIFICATION: Past animal and human clinical trials have demonstrated TRE to be beneficial in realigning circadian rhythm, improve coronary artery disease (CAD) and peripheral artery disease (PAD) through the reduction in calorie intake, and promote cell signalling and repair pathways during the fasting period. TRE has not been tested in patients with CAD or other heart diseases but has shown to improve comorbid conditions (diabetes and hypertension) and improve metabolic profiles (blood pressure, hemoglobin A1c, fasting glucose, insulin sensitivity, and lipid profiles. Additionally, TRE when combined with exercise, such as in cardiac rehabilitation programs, improves VO2 peak and reduces fat mass compared to exercise alone. The proposed study will deliver a TRE intervention in combination with the cardiac rehabilitation program and is expected to be feasible, safe, and improve outcomes of cardiac rehabilitation.
OBJECTIVES: The primary aim of this study is to evaluate the feasibility (adherence) and safety (adverse events) of TRE in combination with cardiac rehabilitation.
The secondary aim is to assess the efficacy of the intervention on:
- VO2peak, body composition, fasted glucose, hemoglobin A1c, blood pressure and waist circumference
- Lifestyle behavioral change outcomes (dietary intake, dietary quality, physical activity, perceived stress)
4.Cardiac rehabilitation adherence
Exploratory aims of the study include identifying sex differences (equal recruitment of males and females) and participants' experience with TRE (including confidence in maintaining this eating pattern or modifications to increase adherence).
RESEARCH METHOD 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 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. Participants randomized to the TRE group will be asked to eat only between 11 am and 7 pm for the duration of the cardiac rehabilitation program (~16 weeks). Adherence will be collected via twice daily text messages asking participants to respond with the time they started and stopped eating. Safety will be collected by self-report and medical records. Efficacy outcomes will be assessed by cardiopulmonary exercise test, blood draw, dual x-ray absorptiometry, 3-day diet records, accelerometers, and questionnaires. Study outcomes will be measured at baseline and at the end of the cardiac rehabilitation program.
SAMPLE SIZE A priori sample size for recruitment (n=60, 30 per group, equal recruitment of sex) was not fully achieved within the study period. Over the course of two years, the study efforts successfully recruited 30 male participants within the first 12 months of recruitment. Only 15 female participants were recruited after 2 years of recruitment efforts. The lower enrollment rate of females reflects both time limitations on the recruitment window and less females attending cardiac rehabilitation within the study criteria. The study team decided to end recruitment at n=45 (30 males, 15 females) after 2 years of recruitment due to personnel limitations
STATISTICAL ANALYSIS Participant characteristics will be summarized using descriptive statistics. For adherence, both the text message response rate and adherence rate to the 16-hour daily fast will be reported. The change in caloric intake, diet quality, physical activity and efficacy outcomes will be compared between groups by analysis of covariance with baseline values as covariates. Relative risk will be used to compare the incidence of safety outcomes between groups. The primary analysis will be intention to treat and performed with both sexes combined. Secondary analyses will be performed separately in each sex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cardiac rehabilitation | Active comparator | Behavioral: Standard cardiac rehabilitationThe 16-week program consists of physician-directed risk factor management, an individualized aerobic and resistance exercise prescription, and virtual education on disease management and lifestyle behaviors (including exercise safety, stress management, and heart-healthy nutrition), and an assessment with a registered dietitian and individualized recommendations for a heart-healthy diet. Additionally, selected patients with identified issues such as depression, anxiety, trouble sleeping, anger and social and emotional issues will receive one-on-one counselling with a psychologist or social worker. |
| Standard cardiac rehabilitation + TRE | Experimental | Behavioral: Standard cardiac rehabilitation, Behavioral: Time-Restricted EatingParticipants in this group will receive the same standard assessment and individualized recommendations as the comparator group, but will also be counselled to restrict their eating to between 11 am and 7 pm during the program starting the evening of the consultation. They will also be advised to perform their home-based exercise sessions during the fasting period in the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard cardiac rehabilitationStandard, multi-dimensional cardiac rehabilitation program. | Behavioural | Standard cardiac rehabilitation, Standard cardiac rehabilitation + TRE |
| Time-Restricted EatingCounselling to restrict their eating to between 11 am and 7 pm and to consume water-only for the remaining 16 hours per day | Behavioural | Standard cardiac rehabilitation + TRE |
Primary outcome
Adherence to the daily ≥16-hour fast for the 16-weeks of the cardiac rehabilitation program.
Time frame: Averaged over the 16 weeks of the intervention
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.
Cardiorespiratory fitness as measured by peak volume of oxygen consumption (VO2peak)
Time frame: 16 weeks
Assessed by an incremental, to-maximum cardiopulmonary treadmill exercise test.
Fat mass
Time frame: 16 weeks
Assessed by dual absorptiometry x-ray (DXA) scan.
11 secondary outcomes
Symptoms from TRE
Time frame: 16 weeks
Seattle Angina Questionnaire score
Time frame: 16 weeks
Adverse events
Time frame: 1-year
Fat-free mass
Time frame: 16 weeks
Hemoglobin A1c
Time frame: 16 weeks
Blood pressure
Time frame: 16 weeks
Waist circumference
Time frame: 16 weeks
Fasted blood glucose
Time frame: 16 weeks
Metabolic syndrome
Time frame: 16 weeks
Lipid profile
Time frame: 16 weeks
Health-related quality of life measured by the RAND-36 Physical Component Summary
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Oh, MD study director
University Health Network, Toronto
Amy Kirkham, PhD principal investigator
University of Toronto, KITE Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard cardiac rehabilitation and Time-Restricted Eating in people with Coronary Artery Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the daily ≥16-hour fast for the 16-weeks of the cardiac rehabilitation program. (time frame: Averaged over the 16 weeks of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.