Circadian Misalignment and Energy Balance

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT03663530
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Meal times — BEHAVIORAL
    Meal times vary based on the arm: aligned or misaligned

Study Details

Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.

Key Dates

Start date
Jan 1, 2019
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Circadian misalignment
    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.
  • Active Comparator: Circadian alignment
    Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM.

Primary Outcome Measure

Energy expenditure [ Time Frame: Change over 2-week period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Diane Hawkins
[email protected]
Marie-Pierre St-Onge, PhD (PRINCIPAL_INVESTIGATOR)

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By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Columbia University Irving Medical Center· New York, NY

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