Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation (TRE x ICR)

Impact of Time Restricted Eating on Exercise Capacity, Cardiometabolic Parameters, and Trimethylamine N-oxide (TMAO) Levels in Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation

The purpose of this study is to see if reducing the number of hours during which one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health (i.e. blood sugar levels and blood pressure). The study also aims to assess changes in exercise capacity and trimethylamine N-oxide (TMAO) levels in response to Time Restricted Eating (TRE) and Intensive Cardiac Rehabilitation (ICR) versus ICR alone. TMAO is a metabolite, or a substance, produced during digestion and metabolism. Preliminary data illustrates a correlation between high levels of TMAO and higher risk of cardiovascular disease and mortality. We will also be looking at participants' long-term cardiovascular health status after they complete the ICR program.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: ICR (Intensive Cardiac Rehabilitation); Behavioral: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Altman Clinical and Translational Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18-75 years
2. Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program
3. Established diagnosis of coronary artery disease (concomitant systolic or diastolic HF is allowable)
4. Own a smartphone (Apple iOS or Android OS)
5. If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs, no dose adjustments will be allowed during the study period.

Exclusion Criteria:

1. Taking insulin within the last 6 months.
2. Known inflammatory and/or rheumatologic disease.
3. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
4. Pregnant or breast-feeding women.
5. Shift workers with variable (e.g. nocturnal) hours.
6. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
7. Planned international travel during study period.
8. Systolic HF alone.
9. Heart transplant within the past 1 year.
10. Presence of left ventricular assist device.
11. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
12. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
13. History of adrenal disease.
14. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
15. History of type I diabetes with ongoing insulin dependence.
16. History of eating disorders.
17. History of cirrhosis.
18. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
19. History of HIV/AIDS.
20. Currently enrolled in a weight-loss or weight-management program. This does not include UC San Diego's Cardiac Rehabilitation Programs.
21. On a special or prescribed diet for other reasons (e.g. Celiac disease).
22. Currently taking any medication that is meant for, or has a known effect on, appetite.
23. Any history of surgical intervention for weight management.
24. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
25. Baseline eating window <14 hours per day as documented on mCC app.
26. Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: ICR (Intensive Cardiac Rehabilitation); 20 patients will be randomly assigned to the standard of care group, which will receive the standard health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR" group.	Behavioral: ICR (Intensive Cardiac Rehabilitation); Participants in this arm will not have to adopt a 10-hour eating window while taking part in UCSD's 9-week ICR program.
Experimental: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating); 20 patients will be randomly assigned to the Time-Restricted Eating (TRE) group which will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and nutritional wellness guidelines that are required of UCSD's 9-week ICR program, referred to as the "ICR x TRE" group.	Behavioral: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating); Participants in this arm will adhere to a daily, consistent 10-hour eating window while undergoing UCSD's 9-week ICR program to see if there is an improvement on cardiometabolic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Exercise Capacity (MetS)	Exercise Capacity	Baseline and Week 1-9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL cholesterol	LDL cholesterol (mg/dL)	Baseline and Week 9
Change in non-HDL cholesterol	non-HDL cholesterol (mg/dL)	Baseline and Week 9
Change in Triglycerides	Triglycerides (mg/dL)	Baseline and Week 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TMAO levels	TMAO levels (uM)	Baseline and Week 9

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: The Cleveland Clinic; Salk Institute for Biological Studies
• Investigators: Principal Investigator: Pam R Taub, MD, UC San Diego Health

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): September 11, 2023
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Circadian Rhythm; Cardiac Rehabilitation; Time Restricted Eating
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 200530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No