Time Restricted Eating and Cardiac Rehabilitation

NCT05075317 | Recruiting

• 1 other identifier: 21-5510
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease

Keywords

Time-Restricted Eating; Cardiac Rehabilitation; Cardiorespiratory Fitness; Caloric Restriction; Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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

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

  Assessed by an incremental, to-maximum cardiopulmonary treadmill exercise test.

  16 weeks

• Fat mass

  Assessed by dual absorptiometry x-ray (DXA) scan.

  16 weeks

Secondary Outcomes (11)

• Symptoms from TRE

  16 weeks

• Seattle Angina Questionnaire score

  16 weeks

• Adverse events

  1-year

• Fat-free mass

  16 weeks

• Hemoglobin A1c

  16 weeks

Other Outcomes (6)

• Macronutrient ratios

  16 weeks

• Caloric intake

  16 weeks

• Cardiac rehabilitation adherence

  16 weeks

Study Arms (2)

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.

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.

Behavioral: Standard cardiac rehabilitation; Behavioral: Time-Restricted Eating

Interventions

Standard cardiac rehabilitation BEHAVIORAL

Standard, multi-dimensional cardiac rehabilitation program.

Standard cardiac rehabilitation; Standard cardiac rehabilitation + TRE

Time-Restricted Eating BEHAVIORAL

Counselling to restrict their eating to between 11 am and 7 pm and to consume water-only for the remaining 16 hours per day

Standard cardiac rehabilitation + TRE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Toronto Rehabilitation Institute, University Health Network

Toronto, Ontario, M4G 1R7, Canada

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Intermittent Fasting

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Paul Oh, MD

  University Health Network, Toronto

  STUDY DIRECTOR

• Amy Kirkham, PhD

  University of Toronto, KITE Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Kirkham, PhD

CONTACT

‭(416) 946-4069‬; amy.kirkham@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: October 12, 2021
• Study Start: July 11, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)