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Meal Timing for Obesity (CM Trial)
N/A
Recruiting
Led By Marie-Pierre St-Onge, PhD
Research Sponsored by Columbia 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 4 weeks
Awards & highlights
CM Trial Summary
This trial suggests that when meals and sleep are not timelined correctly, it alters how the body processes information related to food and sleep. This could have an effect on weight regulation.
Who is the study for?
This trial is for adults with obesity (BMI of 25-34.9) who usually sleep at least 7 hours, starting at or before 4 AM, and eat within an hour of waking up. It's open to all races and ethnicities. People can't join if they have sleep disorders, severe insomnia, psychiatric conditions, recent significant weight changes, are pregnant or post-partum within a year, have high alcohol intake or substance abuse history.Check my eligibility
What is being tested?
The study investigates how the timing of meals and sleep affects body weight regulation without changing sleep duration. It aims to provide guidance on meal and sleep scheduling that could benefit shift workers or those experiencing jetlag.See study design
What are the potential side effects?
Since this trial involves non-medical interventions related to meal times and sleeping patterns rather than drugs or medical procedures, typical medication side effects are not expected.
CM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body composition
Energy expenditure
Nutritional intakes
Secondary outcome measures
Appetite
Hormones
Resting state functional neuroimaging
+1 moreOther outcome measures
Circadian rhythms
CM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Circadian misalignmentExperimental Treatment1 Intervention
Meals in this condition will be delayed by 4 hours relative to the circadian alignment condition. Food intake during this period will be from 1 PM to 11 PM.
Group II: Circadian alignmentActive Control1 Intervention
Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,438 Previous Clinical Trials
2,448,753 Total Patients Enrolled
40 Trials studying Obesity
5,952 Patients Enrolled for Obesity
NYU Langone HealthOTHER
1,373 Previous Clinical Trials
841,078 Total Patients Enrolled
25 Trials studying Obesity
10,953 Patients Enrolled for Obesity
Marie-Pierre St-Onge, PhDPrincipal Investigator - Columbia University
Columbia University
8 Previous Clinical Trials
399 Total Patients Enrolled
4 Trials studying Obesity
177 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking beta blockers.I have gained or lost more than 5% of my weight in the last 3 months or have been actively trying to change my weight.I regularly take pain or anti-inflammatory medication.I am experiencing depression or am on anti-depressants.I have restless leg syndrome and problems with my body clock.I have had surgery on my digestive system.I do not have dementia or significant memory problems.I am taking medication for my mental health or sleep.I eat within an hour of waking up at least 5 days a week.I have been diagnosed with sleep apnea or am at high risk according to the Berlin questionnaire.I am currently pregnant or have given birth within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Circadian misalignment
- Group 2: Circadian alignment
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: NCT03663530 — N/A
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