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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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

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 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.

0 / 8Eligibility criteria met