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Circadian Time Restricted Eating for Time-Restricted Feeding (CTRE Trial)
N/A
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7.5 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how meal timing relative to our natural body clock affects our health & weight. They hope to find if an intervention can help improve cardiometabolic health & weight.
Who is the study for?
This trial is for healthy adults who are overweight or obese with a BMI of at least 27. Participants should not have cardiovascular diseases, uncontrolled hypertension, diabetes, or a history of significant drug/alcohol use. They must be non-smokers without irregular work hours in the past year and no major travel recently.
What is being tested?
The study examines if eating according to one's circadian rhythm can improve heart health and aid weight loss. Overweight individuals will follow a specific meal schedule for 46 days while researchers track changes in their cardiometabolic health both at home and in the lab.
What are the potential side effects?
Since this intervention involves dietary timing rather than medication, side effects may include hunger outside of eating windows, potential headaches or irritability due to changes in meal patterns, but no medicinal side effects are expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7.5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7.5 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Blood Pressure
Changes in Glucose
Changes in Heart Rate
+5 moreSecondary study objectives
Changes in Body Fat Percentage
Changes in Body Mass Index
Changes in Weight
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Circadian Based Time Restricted EatingExperimental Treatment1 Intervention
Personalized restricted eating protocol approximately \~4h before DLMO or sleep onset.
Group II: ControlActive Control1 Intervention
Continue with normal dietary habits and behaviors.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,299 Total Patients Enrolled
30 Trials studying Obesity
9,346 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have heart problems.You can participate in the study even if you are overweight or obese, but you must be in good health.You have problems with your sleep pattern or biological clock.You have problems with your digestive system.You have cancer.You have a medical condition related to hormones or your body's ability to process nutrients.You have a disorder related to your nervous system.You have an infectious disease.People who are generally healthy but may be overweight or obese.You have an immune system disorder.You have a medical condition that affects your breathing.You have problems with your kidneys or urinary tract.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Circadian Based Time Restricted Eating
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Obesity Patient Testimony for trial: Trial Name: NCT05628012 — N/A