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

August 19, 2024 updated by: Pam Taub, MD, University of California, San Diego

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Victoria A Green, BS
  • Phone Number: 858-246-2406

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Exercise Capacity (MetS)
Time Frame: Baseline and Week 1-9
Exercise Capacity
Baseline and Week 1-9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in LDL cholesterol
Time Frame: Baseline and Week 9
LDL cholesterol (mg/dL)
Baseline and Week 9
Change in non-HDL cholesterol
Time Frame: Baseline and Week 9
non-HDL cholesterol (mg/dL)
Baseline and Week 9
Change in Triglycerides
Time Frame: Baseline and Week 9
Triglycerides (mg/dL)
Baseline and Week 9

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in TMAO levels
Time Frame: Baseline and Week 9
TMAO levels (uM)
Baseline and Week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cleveland Clinic
Salk Institute for Biological Studies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pam R Taub, MD, UC San Diego Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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