Time-Restricted Eating for Coronary Heart Disease

(TREat-CR Trial)

Recruiting at 1 trial location

Overseen By Amy Kirkham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Eating disorder, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

60 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 3 6 7 8}

How 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. ^{1 9 10 11 12}

Research Team

Paul Oh, MD

Principal Investigator

University Health Network, Toronto

Amy Kirkham, PhD

Principal Investigator

University of Toronto, KITE Research Institute

Eligibility 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.

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

Treatment Details

Interventions

• Standard cardiac rehabilitation
• Time-Restricted Eating

Trial Overview 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.

Participant Groups

Group I: Standard cardiac rehabilitation + TRE Experimental Treatment 2 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 rehabilitation Active Control 1 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

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Findings from Research

Time-restricted eating (TRE) is proposed as a promising nutritional strategy within cardiac rehabilitation (CR) programs to improve cardiovascular disease (CVD) outcomes, addressing barriers to dietary adherence and enhancing overall program effectiveness.

Preliminary data suggest that TRE is safe and may have beneficial cardiometabolic effects, especially when combined with exercise, although more research is needed to fully establish its efficacy in CR settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: A Novel Dietary Strategy for Cardiac Rehabilitation. Small, S., Iglesies-Grau, J., Gariepy, C., et al.[2023]

A study involving 497 patients compared a standard 8-week cardiac rehabilitation program (CRP) to a brief 2-week intensive CRP, finding that both programs significantly improved patients' functional capacity, adherence to the Mediterranean diet, and quality of life after 12 months.

The results showed no significant differences in the occurrence of cardiovascular events between the two groups, suggesting that the intensive CRP could be a viable alternative to the standard program for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Más por Menos) randomized trial. Castro-Conde, A., Abeytua, M., Arrarte Esteban, VI., et al.[2021]

The Partners Together in Health (PaTH) intervention showed improved trends in healthy eating behaviors for both coronary artery bypass surgery patients and their spouses, suggesting that involving partners in rehabilitation can enhance dietary adherence.

Despite the positive impact on eating habits, the study found no significant differences in physical activity levels between the PaTH intervention and usual care groups at 3 or 6 months, with both groups falling short of national physical activity guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of partners together in health intervention on physical activity and healthy eating behaviors: a pilot study. Yates, BC., Norman, J., Meza, J., et al.[2021]

A novel telehealth-enhanced hybrid cardiac rehabilitation (THCR) program was developed using user-centered design and implementation science principles, addressing barriers to uptake identified through interviews with healthcare stakeholders.

Usability testing of the THCR prototype revealed important themes such as ease of use and technology disruptions, leading to design improvements that enhance the program's feasibility and acceptability for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study. Duran, AT., Keener-DeNoia, A., Stavrolakes, K., et al.[2023]

Cardiac rehabilitation (CR) programs lead to improvements in fitness for patients after heart events, with a mean age of participants being 59.5 years, but younger individuals and women are underrepresented in these studies.

The study suggests that a more tailored 'Precision Medicine' approach to CR could enhance benefits for all patient subgroups, as current programs may not fully address the diverse needs of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit, Female or Fifty-Is Cardiac Rehabilitation "Fit" for Purpose for All? A Systematic Review and Meta-Analysis With Meta-Regression. Smith, M., Orchard, J., La Gerche, A., et al.[2022]

Intensive behavioral interventions, such as counseling, are effective in promoting long-term health behavior changes in patients with coronary heart disease and abdominal obesity, leading to weight reduction, healthier eating, and increased physical activity.

These comprehensive cardiac rehabilitation programs have been shown to improve key clinical outcomes, highlighting their importance in secondary prevention efforts for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallmarks of preventive counseling in coronary heart disease patients with abdominal obesity]. Pogosova, NV., Sokolova, OY., Salbieva, AO., et al.[2019]

In a study of 54,163 patients with coronary heart disease, those who participated in exercise-based cardiac rehabilitation for longer than 90 days had nearly half the mortality risk compared to those who did not participate at all, highlighting the program's effectiveness in improving survival rates.

Patients who did not engage in exercise-based rehabilitation also faced a higher risk of reduced working capacity, emphasizing the importance of these programs in maintaining not just health but also the ability to work after cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-Based Cardiac Rehabilitation: Secondary Data Analyses of Mortality and Working Capacity in Germany, 2010-2017. Gabrys, L., Soff, J., Thiel, C., et al.[2023]

High-risk cardiac patients showed significant improvements in exercise capacity (VO2peak) and heart function (LVEF) after participating in a 6 to 8 week cardiac rehabilitation program, with no serious cardiovascular events reported during the training.

The improvements in both VO2peak and LVEF in high-risk patients were comparable to those seen in control participants, indicating that cardiac rehabilitation is safe and effective for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. Choi, HE., Kim, C., Sohn, Y.[2020]

A 4-week time-restricted eating (TRE) intervention significantly reduced markers of cardiovascular disease risk, including lowering TNF-α and glucose levels, in a study of 12 middle-aged male cyclists.

TRE also increased high-density lipoprotein (HDL) cholesterol levels, suggesting that this dietary approach can enhance cardiovascular health alongside regular endurance training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A self-selected 16:8 time-restricted eating quasi-experimental intervention improves various markers of cardiovascular health in middle-age male cyclists. Waldman, HS., Witt, CR., Grozier, CD., et al.[2023]

Time-restricted eating (TRE) significantly reduces cardiovascular risk factors, including systolic blood pressure, body weight, body mass index, fat mass, and blood glucose levels, based on a systematic review and meta-analysis of various studies.

The analysis suggests that optimal TRE strategies vary by population, with specific recommendations for feeding windows and timing that can maximize health benefits for different age and gender groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The optimal time restricted eating interventions for blood pressure, weight, fat mass, glucose, and lipids: A meta-analyses and systematic review. Liang, X., Chen, J., An, X., et al.[2023]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

A study involving 144 acute coronary syndrome survivors showed that a patient-centered modular prevention program significantly reduced key risk factors like cholesterol, blood pressure, and body mass index compared to conventional care over 3 months.

Participants in the modular group also had better smoking cessation rates and achieved similar risk levels as those attending traditional cardiac rehabilitation, highlighting its effectiveness as an alternative for those not accessing standard programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered modular secondary prevention following acute coronary syndrome: a randomized controlled trial. Redfern, J., Briffa, T., Ellis, E., et al.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: A Novel Dietary Strategy for Cardiac Rehabilitation. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Más por Menos) randomized trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of partners together in health intervention on physical activity and healthy eating behaviors: a pilot study. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Fit, Female or Fifty-Is Cardiac Rehabilitation "Fit" for Purpose for All? A Systematic Review and Meta-Analysis With Meta-Regression. [2022]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Hallmarks of preventive counseling in coronary heart disease patients with abdominal obesity]. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise-Based Cardiac Rehabilitation: Secondary Data Analyses of Mortality and Working Capacity in Germany, 2010-2017. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A self-selected 16:8 time-restricted eating quasi-experimental intervention improves various markers of cardiovascular health in middle-age male cyclists. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The optimal time restricted eating interventions for blood pressure, weight, fat mass, glucose, and lipids: A meta-analyses and systematic review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Patient-centered modular secondary prevention following acute coronary syndrome: a randomized controlled trial. [2014]