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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
Must not have
Taking beta blockers, as this can interfere with melatonin secretion
Depression (score >13 on Beck Depression Inventory II) or taking anti-depressive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking beta blockers.
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I am experiencing depression or am on anti-depressants.
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I have restless leg syndrome and problems with my body clock.
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I have had surgery on my digestive system.
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I do not have dementia or significant memory problems.
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I am taking medication for my mental health or sleep.
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I have been diagnosed with sleep apnea or am at high risk according to the Berlin questionnaire.
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I am currently pregnant or have given birth within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body composition
Energy expenditure
Nutritional intakes
Secondary study objectives
Appetite
Hormones
Resting state functional neuroimaging
+1 more
Other study objectives
Circadian rhythms

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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,308 Total Patients Enrolled
41 Trials studying Obesity
5,998 Patients Enrolled for Obesity
NYU Langone HealthOTHER
1,397 Previous Clinical Trials
861,800 Total Patients Enrolled
25 Trials studying Obesity
10,587 Patients Enrolled for Obesity
Marie-Pierre St-Onge, PhDPrincipal Investigator - Columbia University
Columbia University
9 Previous Clinical Trials
423 Total Patients Enrolled
4 Trials studying Obesity
177 Patients Enrolled for Obesity

Media Library

Meal times Clinical Trial Eligibility Overview. Trial Name: NCT03663530 — N/A
Obesity Research Study Groups: Circadian misalignment, Circadian alignment
Obesity Clinical Trial 2023: Meal times Highlights & Side Effects. Trial Name: NCT03663530 — N/A
Meal times 2023 Treatment Timeline for Medical Study. Trial Name: NCT03663530 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03663530 — N/A
~5 spots leftby Jul 2025
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