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ICR + Time-Restricted Eating for Coronary Artery Disease (TRE x ICR Trial)
N/A
Recruiting
Led By Pam R Taub, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Enrollment and planned participation in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 1-9
Awards & highlights
TRE x ICR Trial Summary
This trial will help assess whether reducing the number of hours one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health.
Who is the study for?
This trial is for adults aged 18-75 with coronary artery disease who are enrolled in UC San Diego's 9-week Intensive Cardiac Rehabilitation Program. Participants must be on stable doses of cardiovascular medications, own a smartphone, and not have conditions like active cancer (except non-melanoma skin cancer), inflammatory diseases, type I diabetes requiring insulin, or severe kidney disease.Check my eligibility
What is being tested?
The study tests if Time-Restricted Eating (TRE) combined with Intensive Cardiac Rehabilitation (ICR) can improve cholesterol levels, blood sugar, blood pressure, exercise capacity and reduce TMAO levels compared to just ICR. TRE involves eating within a certain number of hours each day.See study design
What are the potential side effects?
Potential side effects may include changes in energy levels due to altered eating times which could affect metabolism and mood. There might also be initial discomfort as the body adjusts to new meal schedules.
TRE x ICR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am enrolled in UC San Diego's 9-week heart rehab program.
Select...
I am on heart or diabetes medication and cannot change the dose during the study.
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I am between 18 and 75 years old.
TRE x ICR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 1-9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 1-9
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Exercise Capacity (MetS)
Secondary outcome measures
Change in LDL cholesterol
Change in Triglycerides
Change in non-HDL cholesterol
Other outcome measures
Change in TMAO levels
TRE x ICR Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)Experimental Treatment1 Intervention
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.
Group II: ICR (Intensive Cardiac Rehabilitation)Placebo Group1 Intervention
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.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure that affects the heart's pumping ability.You have a device supporting the left side of your heart.I am on heart or diabetes medication and cannot change the dose during the study.I am currently in a weight-loss or management program, not including UC San Diego's Cardiac Rehab.Not using the smartphone app to record at least two meals a day for three or more days during the initial period.I have had changes in my thyroid medication doses in the last 3 months.I have a history of adrenal gland problems.I have had surgery to help manage my weight.You currently use a lot of tobacco or illegal drugs, or have been treated for alcohol abuse in the past.I have been using insulin in the past 6 months.You are responsible for taking care of someone who needs help during the night.My heart rhythm is stable, not including controlled atrial fibrillation/flutter.I have a history of cirrhosis.I am enrolled in UC San Diego's 9-week heart rehab program.I have type 1 diabetes and need insulin.You have a history of eating disorders.I have a history of HIV/AIDS.I have a diagnosed inflammatory or rheumatologic condition.I have had a heart transplant in the last year.I am on medication that affects my appetite.You are following a special diet for medical reasons, like Celiac disease.I have advanced chronic kidney disease or am on dialysis.You eat within a time period of less than 14 hours per day, as shown on the mCC app.I have been diagnosed with coronary artery disease.People who work different hours, like at night, are not allowed to participate.I am currently being treated for cancer, except for non-melanoma skin cancer.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: ICR (Intensive Cardiac Rehabilitation)
- Group 2: ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor need additional participants?
"Affirmative, the listing on clinicaltrials.gov reveals that this medical investigation is actively enrolling participants as of October 3rd 2022. The trial was first published in September 2021 and requires 40 patients from one location."
Answered by AI
How many volunteers are participating in the experiment?
"Affirmative, the information found on clinicaltrials.gov confirms that recruitment for this study is currently ongoing. The trial was first listed on September 2nd 2021 and has since been updated as recently as October 3rd 2022. It calls for 40 participants at a single site."
Answered by AI
Are geriatric individuals able to partake in the current research?
"The minimum and maximum age for enrollment as per the study's criteria is 18 years old and 75 years old respectively."
Answered by AI
Could I potentially meet the requirements to join this experimental program?
"This medical research is enrolling 40 individuals aged 18-75 that are suffering from coronary artery disease. Key criteria for inclusion include not having any alterations to cardiovascular, antihypertensive, or antidiabetic medications and owing a smartphone with either iOS or Android OS. Furthermore, participants must have signed up for the 9 week long Intensive Cardiac Rehabilitation Program at UC San Diego."
Answered by AI
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