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Time-Restricted Eating for Coronary Heart Disease (TREat-CR Trial)

N/A

Recruiting

Led By Paul Oh, MD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Body mass index <18.5 kg/m^2 or clinical signs of cachexia

Type 2 diabetes that requires exogenous insulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the feasibility and safety of using a time-restricted eating diet during cardiac rehabilitation, and if it has any benefits compared to cardiac rehabilitation alone.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated in this summary, potential side effects from time-restricted eating may include hunger pangs outside of the eating window, fatigue during adjustment periods to new meal times, potential headaches or irritability associated with changes in blood sugar levels.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am underweight or show signs of severe weight loss.

Select...

I have type 2 diabetes and need insulin injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to the daily ≥16-hour fast for the 16-weeks of the cardiac rehabilitation program.

Cardiorespiratory fitness as measured by peak volume of oxygen consumption (VO2peak)

Fat mass

Secondary study objectives

Adverse events

Blood pressure

Fasted blood glucose

+8 more

Other study objectives

Caloric intake

Cardiac rehabilitation adherence

Macronutrient ratios

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time-Restricted Eating

2019

N/A

~160

0 / 2Eligibility criteria met