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OpenTrials
Active, Not Recruiting

NCT Number: NCT05014880

Impact of Time Restricted Eating on 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
  • 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).
  • 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.
  • History of stage 4 or 5 chronic kidney disease or requiring dialysis.
  • History of HIV/AIDS.
  • Currently enrolled in a weight-loss or weight-management program. This does not include UC San Diego's Cardiac Rehabilitation Programs.
  • On a special or prescribed diet for other reasons (e.g. Celiac disease).
  • Currently taking any medication that is meant for, or has a known effect on, appetite.
  • Any history of surgical intervention for weight management.
  • Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
  • Baseline eating window <14 hours per day as documented on mCC app.
  • Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).

Treatment and study plan

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 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.

Primary outcomes

  1. Change in Exercise Capacity (MetS)

    Time frame: Baseline and Week 1-9

    Exercise Capacity

Secondary outcomes

  1. Change in LDL cholesterol

    Time frame: Baseline and Week 9

    LDL cholesterol (mg/dL)

  2. Change in non-HDL cholesterol

    Time frame: Baseline and Week 9

    non-HDL cholesterol (mg/dL)

  3. Change in Triglycerides

    Time frame: Baseline and Week 9

    Triglycerides (mg/dL)

Other outcomes

  1. Change in TMAO levels

    Time frame: Baseline and Week 9

    TMAO levels (uM)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Salk Institute for Biological Studies
  • The Cleveland Clinic

Registry information

Official study title

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

Acronym: TRE x ICR

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Aug 20, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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