Circadian Misalignment and Energy Balance Study

This study is looking at how the timing of your meals, specifically in relation to your sleep, affects your body's energy balance. Researchers want to understand if eating at different times after waking up impacts your health. They will compare two groups: one eating soon after waking, and another eating several hours later. The study aims to see how these different meal times affect your energy use, body makeup (like fat and muscle), and what you eat over 2 to 4 weeks. You might be able to join if you are between 20 and 49 years old, have a BMI between 20 and 34.9 kg/m2, and typically sleep at least 7 hours a night. The study's current status is unclear, and it plans to enroll 42 participants.

Study design
This is an interventional study planning to enroll 42 participants. It is a crossover study, meaning participants will experience both meal timing conditions.
What's involved
You will participate in two phases where meal times are controlled, with constant sleep periods. Each phase includes measurements after 3 and 14 days, followed by a 4-week period where you follow the prescribed meal times at home.
Compensation
Not stated in the trial record.
Follow-up
Measurements for energy expenditure are taken over a 2-week period, and body composition and nutritional intakes are measured over a 4-week period.

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NCT03663530

Circadian Misalignment and Energy Balance

Recruiting
NAAges 20–49InterventionalPrevention
Columbia University
~42 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Meal times

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Energy expenditure
Measured over Change over 2-week period
+2 more outcomes measured
Obesity
1 sites across 1 states
New York1
  • Marie-Pierre St-Onge, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

All racial and ethnic groups
Body mass index 20-34.9 kg/m2
Average sleep duration ≥7 hour/night, assessed during 2-week screening period
Eat within 1 hour of awakening at least 5 days/week
Midpoint of sleep at 4 AM or earlier

Exclusion

\<10 nights of sleep \<7 hour during the 2-week screening period
Daytime napping
Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score \>10
Current or past psychiatric disorder, including eating disorders and seasonal affective disorder
Any psychological or psychiatric disorder deemed to interfere with study outcomes
Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers \<3 years)
Night and rotating shift work
Travel across time zones within 4 wk of the study
History of drug or alcohol abuse or excessive alcohol consumption (\>3 drinks/day for men or 2 for women)
Recent weight change (\>5% gain or loss of body weight over past 3 months) or active participation in diet or weight loss program in previous 3 months; any weight loss procedure
Pregnancy or \<1 year post-partum
Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score)
Depression (score \>13 on Beck Depression Inventory II) or taking anti-depressive medications
Restless leg syndrome and circadian rhythm disorders
Dementia or cognitive impairments
Taking psychoactive or hypnotic medications
Taking chronic analgesic or anti-inflammatory medications
Having had gastrointestinal surgery, including gastric bypass surgery
Restrained eating or abnormal scores on the Three Factor Eating Questionnaire
Contraindications for magnetic resonance imaging scanning
Hematocrit \<30%
Taking beta blockers, as this can interfere with melatonin secretion
  • Energy expenditureChange over 2-week period

    Metabolic chamber

  • Body compositionChange over 4-week period

    Quantitative magnetic resonance

  • Nutritional intakes4 weeks

    3-day food records