Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction (NCT05870982) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction
United States162 participantsStarted 2023-07-11
Plain-language summary
The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are:
1. How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors?
2. How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors?
Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction.
1. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support.
2. They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult males and females with a BMI of 27-45 kg/m2
* Age, 18-65 years old
* Passing medical and physical screening, and analysis of blood and urine screening samples
* Individuals who are not currently following an intermittent fasting or TRE dietary regimen (i.e., eating across less than a 10-hour period during the day).
* Own a smartphone
* Live or work within 45 minutes of the Anschutz Health \& Wellness Center (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects)
* No plans to relocate within the next 12 months
* Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment.
* Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
Exclusion Criteria:
* Pregnancy or lactation for women (women who are \>6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months)
* Weight loss \>5kg in past 3 months for any reason except post-partum weight loss, weight gain \>5kg in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study
* Weight loss o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.