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

NCT05014880 | Active Not Recruiting DMC

• 1 other identifier: 200530
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Time Restricted Eating; Circadian Rhythm; Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Exercise Capacity (MetS)

  Exercise Capacity

  Baseline and Week 1-9

Secondary Outcomes (3)

• Change in LDL cholesterol

  Baseline and Week 9

• Change in non-HDL cholesterol

  Baseline and Week 9

• Change in Triglycerides

  Baseline and Week 9

Other Outcomes (1)

• Change in TMAO levels

  Baseline and Week 9

Study Arms (2)

ICR (Intensive Cardiac Rehabilitation)

PLACEBO COMPARATOR

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)

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

EXPERIMENTAL

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)

Interventions

ICR (Intensive Cardiac Rehabilitation) BEHAVIORAL

Participants in this arm will not have to adopt a 10-hour eating window while taking part in UCSD's 9-week ICR program.

ICR (Intensive Cardiac Rehabilitation)

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) BEHAVIORAL

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.

ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years
• Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program
• Established diagnosis of coronary artery disease (concomitant systolic or diastolic HF is allowable)
• Own a smartphone (Apple iOS or Android OS)
• 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.

You may not qualify if:

• Taking insulin within the last 6 months.
• Known inflammatory and/or rheumatologic disease.
• Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
• Pregnant or breast-feeding women.
• Shift workers with variable (e.g. nocturnal) hours.
• Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
• Planned international travel during study period.
• Systolic HF alone.
• Heart transplant within the past 1 year.
• Presence of left ventricular assist device.
• History of adrenal disease.
• History of malignancy undergoing active treatment, except non-melanoma skin cancer.
• History of type I diabetes with ongoing insulin dependence.
• History of eating disorders.
• History of cirrhosis.

Sponsors & Collaborators

• University of California, San Diego: lead
• Salk Institute for Biological Studies: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Location

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

• Pam R Taub, MD

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: September 2, 2021
• Primary Completion: September 11, 2023
• Study Completion: January 31, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)