Time-Restricted Eating for Coronary Heart Disease
(TREat-CR Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byPaul Oh, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Toronto
Disqualifiers: Eating disorder, Pregnancy, Diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Time-Restricted Eating for Coronary Heart Disease?
Time-Restricted Eating (TRE) is suggested as a promising nutrition strategy to enhance cardiac rehabilitation (CR) by potentially improving cardiovascular health, as it involves alternating periods of fasting and eating, which may have beneficial effects on heart health. Although direct research on TRE within CR programs is limited, preliminary data from other populations indicate it could help reduce cardiovascular disease risk factors and improve outcomes when combined with exercise.
12345Is time-restricted eating safe for humans?
Time-restricted eating (TRE), which involves alternating periods of fasting and eating, has been studied for its safety and beneficial effects on heart health in various populations. Preliminary data suggest that TRE is generally safe and may have positive impacts on heart health when combined with exercise.
13678How is time-restricted eating different from standard cardiac rehabilitation for coronary heart disease?
Time-restricted eating (TRE) is a unique dietary strategy that involves eating only during specific hours each day, which may help improve heart health by reducing risk factors for heart disease. Unlike standard cardiac rehabilitation, which focuses on exercise and nutrition education, TRE offers a simpler approach that could be easier for patients to follow and may enhance the benefits of traditional rehabilitation programs.
19101112Eligibility Criteria
This trial is for men and women eligible for outpatient cardiac rehabilitation due to coronary artery disease, who are willing to follow the study's procedures. It excludes those with communication barriers, night shift workers, recent mothers or pregnant women, individuals with eating disorders or very low body weight, people who eat less than 3 meals a day or have an eating window under 12 hours, and diabetics on insulin.Inclusion Criteria
Willing to accept random assignment and complete the study assessments
My participation helps maintain gender balance in the study.
I am eligible for outpatient cardiac rehab for coronary artery disease.
Exclusion Criteria
Inability to complete the consent form and communicate in English
You eat within a time period of less than 12 hours each day, or you consistently eat fewer than 3 meals each day for the past 3 months.
You have a history of an eating disorder that you have reported yourself.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 16-week cardiac rehabilitation program with or without time-restricted eating (TRE). The TRE group restricts eating to an 8-hour window daily.
16 weeks
Regular virtual education sessions and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adherence to TRE and cardiac rehabilitation outcomes.
4 weeks
Long-term Follow-up
Participants are monitored for adverse events such as re-hospitalizations and recurrent cardiac events.
1 year
Participant Groups
The study is testing if adding time-restricted eating (TRE), where participants eat all their meals within an 8-hour period each day, can improve the benefits of standard cardiac rehabilitation in patients with heart conditions. The effectiveness and safety of TRE as part of cardiac rehab will be evaluated.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard cardiac rehabilitation + TREExperimental Treatment2 Interventions
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.
Group II: Standard cardiac rehabilitationActive Control1 Intervention
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.
Standard cardiac rehabilitation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cardiac Rehabilitation for:
- Secondary prevention of cardiovascular disease
- Improvement of cardiometabolic health parameters
🇪🇺 Approved in European Union as Cardiac Rehabilitation for:
- Cardiovascular disease management
- Rehabilitation post-myocardial infarction
🇨🇦 Approved in Canada as Cardiac Rehabilitation for:
- Heart disease management
- Improvement of cardiovascular risk factors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto Western Hospital, University Health NetworkToronto, Canada
Toronto Rehabilitation Institute, University Health NetworkToronto, Canada
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Who Is Running the Clinical Trial?
University of TorontoLead Sponsor
University Health Network, TorontoCollaborator
References
Time-Restricted Eating: A Novel Dietary Strategy for Cardiac Rehabilitation. [2023]Cardiac rehabilitation (CR) is a multimodal program considered to be the standard of care for secondary prevention of cardiovascular disease (CVD). The primary goals of CR are managing CVD risk factors and improving quality of life. Exercise is the cornerstone, but nutrition education delivered by registered dietitians (RDs) is a core component of CR. Yet patient constraints to adherence to dietary change and limited availability of RDs represent major barriers to the success of completion of nutrition intervention during CR. Therefore, nutritional strategies that reduce CVD risk factors, barriers to adherence, and have capacity for broad dissemination are warranted within CR programs. In this review, we propose time-restricted eating (TRE) as a nutrition strategy to improve the outcomes of CR by drawing on parallels to CVD in other populations and describe the available preliminary data on the efficacy of TRE for CVD. TRE is a dietary strategy that involves alternating periods of fasting and consumption of calories each day. We outline the feasibility, safety, and beneficial cardiometabolic impact of TRE from TRE research in other populations. We also discuss the potential for synergistic benefits of exercise when combined with TRE. Although there is currently limited research on TRE within CR programs, we highlight CR as a unique clinical setting where TRE could play a role in secondary prevention of CVD. Overall, we outline the potential of TRE as a promising nutrition strategy to enhance the benefits of CR.
Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Más por Menos) randomized trial. [2021]Cardiac rehabilitation programs (CRP) are a set of interventions to improve the prognosis of cardiovascular disease by influencing patients' physical, mental, and social conditions. However, there are no studies evaluating the optimal duration of these programs. We aimed to compare the results of a standard vs a brief intensive CRP in patients after ST-segment elevation and non-ST-segment elevation acute coronary syndrome through the Más por Menos study (More Intensive Cardiac Rehabilitation Programs in Less Time).
Effects of partners together in health intervention on physical activity and healthy eating behaviors: a pilot study. [2021]Despite proven efficacy of cardiac rehabilitation (CR) in helping patients initiate physical activity and healthy eating changes, less than 50% of CR participants maintain changes 6 months later.
Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study. [2023]Cardiac rehabilitation (CR) is an evidence-based intervention that improves event-free survival in patients with cardiac conditions, yet
Fit, Female or Fifty-Is Cardiac Rehabilitation "Fit" for Purpose for All? A Systematic Review and Meta-Analysis With Meta-Regression. [2022]Cardiac rehabilitation (CR) is an evidence-based intervention promoting risk factor modification following coronary artery disease events but the relative benefits for patient subgroups is not clear. This review synthesizes the available evidence on the effectiveness of modern CR programs and determines outcomes for age, sex and prior level of fitness.
[Hallmarks of preventive counseling in coronary heart disease patients with abdominal obesity]. [2019]Patients with coronary heart disease (CHD) and abdominal obesity (AO) are a priority group for the most active implementation of secondary prevention efforts. The paper focuses on most challenging issues of cardiovascular risk factors (RFs) correction via comprehensive cardiac rehabilitation (CR) programs in patients with CHD and AO. Based on large randomized clinical trials results, intensive behavioral interventions in the form of counselling are beneficial for such patients especially during the long-term support stage. They produce small but important changes in health behaviors (which translate into weight reduction, more healthy nutrition and higher physical activity) and improve selected intermediate clinical endpoints.
Exercise-Based Cardiac Rehabilitation: Secondary Data Analyses of Mortality and Working Capacity in Germany, 2010-2017. [2023]Exercise-based cardiac rehabilitation is safe and implemented in international cardiac rehabilitation guidelines. Evidence for long-term health effects is scarce and rare for health care service research.
Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. [2020]To examine the effect and safety of cardiac rehabilitation (CR) program in high-risk cardiac patients and compare these results to those of control CR participants without high-risk criteria.
A self-selected 16:8 time-restricted eating quasi-experimental intervention improves various markers of cardiovascular health in middle-age male cyclists. [2023]Time-restricted eating (TRE) is a dietary intervention that may offer some protection against cardiovascular disease (CVD), while also preserving performance in athletes. To date however, research on TRE in an active population has only been conducted in college-age cohorts and the effects of TRE in an older, trained population are less understood. Therefore, the aim of this study was to compare the effects of a 4-wk, 16:8 TRE intervention on markers of CVD risk in middle-age, male cyclists.
The optimal time restricted eating interventions for blood pressure, weight, fat mass, glucose, and lipids: A meta-analyses and systematic review. [2023]No previous systematic review or meta-analysis has evaluated the effect of optimal time-restricted eating (TRE) interventions on cardiovascular (CVD) risk factors. This meta-analysis aimed to illustrate the effect of a suitable TRE on CVD risk factors.
Time restricted eating as a weight loss intervention in adults with obesity. [2021]Time-restricted eating (TRE) is a weight management approach in which food is consumed only within a specific period each day. The simplicity of this approach is appealing, but its efficacy is not known. The aim of this pilot cohort study was to assess adherence to TRE and its effects on weight and lipid profile.
Patient-centered modular secondary prevention following acute coronary syndrome: a randomized controlled trial. [2014]Cardiac rehabilitation (CR) is beneficial for those who attend, but alternative models for nonattenders need investigation. We tested the effectiveness of modular prevention on risk factors in survivors of acute coronary syndrome (ACS) not accessing CR.