Coronary Artery DiseaseTRE x ICRNCT05014880
Impact of Time Restricted Eating on Patients With Coronary Artery Disease (CAD) Undergoing Cardiac Rehabilitation
A study testing ICR (Intensive Cardiac Rehabilitation) and ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) in people with Coronary Artery Disease, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ICR (Intensive Cardiac Rehabilitation) and ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92093
About this study
Official 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
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
- Being tested
- ICR (Intensive Cardiac Rehabilitation), ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
- Keywords
- Time Restricted Eating, Circadian Rhythm, Cardiac Rehabilitation
- Medical subject headings
- Coronary Artery Disease, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICR (Intensive Cardiac Rehabilitation)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Capacity (MetS)
Exercise Capacity
Measured: Baseline and Week 1-9
Secondary outcomes (3)
Change in LDL cholesterol
LDL cholesterol (mg/dL)
Measured: Baseline and Week 9
Change in non-HDL cholesterol
non-HDL cholesterol (mg/dL)
Measured: Baseline and Week 9
Change in Triglycerides
Triglycerides (mg/dL)
Measured: Baseline and Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start2 Sep 2021
- Primary completion11 Sep 2023
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies, The Cleveland Clinic
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam R Taub, MD, Principal investigator, UC San Diego Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014880
- Sponsor's protocol ID
- 200530
- Acronym
- TRE x ICR
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05014880
- Acronym / sponsor ID
- TRE x ICR / 200530
- Conditions
- Coronary Artery Disease
- Keywords
- Time Restricted Eating, Circadian Rhythm, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies, The Cleveland Clinic
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICR (Intensive Cardiac Rehabilitation) | Placebo comparator | Behavioral: 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. |
| ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ICR (Intensive Cardiac Rehabilitation) |
| 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. | Behavioural | ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) |
Primary outcome
Change in Exercise Capacity (MetS)
Time frame: Baseline and Week 1-9
Exercise Capacity
3 secondary outcomes
Change in LDL cholesterol
Time frame: Baseline and Week 9
Change in non-HDL cholesterol
Time frame: Baseline and Week 9
Change in Triglycerides
Time frame: Baseline and Week 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pam R Taub, MD principal investigator
UC San Diego Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICR (Intensive Cardiac Rehabilitation) and ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating) in people with Coronary Artery Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Capacity (MetS) (time frame: Baseline and Week 1-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.