NCT03663530

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
5mo left

Started Jan 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2019Dec 2026

First Submitted

Initial submission to the registry

September 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

7.6 years

First QC Date

September 5, 2018

Last Update Submit

September 8, 2025

Conditions

Obesity

Keywords

Food intakeEnergy expenditureBody compositionMeal timing

Outcome Measures

Primary Outcomes (3)

  • Energy expenditure

    Metabolic chamber

    Change over 2-week period

  • Body composition

    Quantitative magnetic resonance

    Change over 4-week period

  • Nutritional intakes

    3-day food records

    4 weeks

Secondary Outcomes (4)

  • Task-based functional neuroimaging

    Change over 2-week period

  • Resting state functional neuroimaging

    Change over 2-week period

  • Appetite

    4 weeks

  • Hormones

    Change over 2-week period

Other Outcomes (1)

  • Circadian rhythms

    Change over 2-week period

Study Arms (2)

Circadian misalignment

EXPERIMENTAL

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.

Behavioral: Meal times

Circadian alignment

ACTIVE COMPARATOR

Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM.

Behavioral: Meal times

Interventions

Meal timesBEHAVIORAL

Meal times vary based on the arm: aligned or misaligned

Circadian alignmentCircadian misalignment

Eligibility Criteria

Age20 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \<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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

  • Boege HL, Wilson KD, Kilkus JM, Qiu W, Cheng B, Wroblewski KE, Tucker B, Tasali E, St-Onge MP. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults. Sleep Health. 2025 Oct;11(5):590-596. doi: 10.1016/j.sleh.2025.05.003. Epub 2025 Jun 11.

    PMID: 40506285DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Meals

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marie-Pierre St-Onge, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Hawkins

CONTACT

212 305 9379dh3078@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be masked to the true outcomes of the study.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is a 2-period crossover study in which sleep is identical in duration and timing but meals/food intake is varied relative to the sleep episode.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 10, 2018

Study Start

January 1, 2019

Primary Completion

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. We plan to follow the HIPAA privacy rule for de-identification of a dataset before transferring data.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will become available after results of the main aims from the final dataset have been accepted for publication.
Access Criteria
Our methods of data sharing include: mailing CD-ROM containing data or e-mailing data files directly to the requestors. Normally, our data files are available in Excel or SAS format. Other data file formats can also be requested. The study's Statisticians will assist in preparing the required data files for data sharing. fMRI data will be uploaded to a data file sharing repository for anyone to use. These data will be de-identified prior to release.

Locations

US(1)