Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT03663530

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 20 - 49

Healthy Volunteers: Accepted

Interventions

Meal times

Study Details

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.

Conditions

Obesity

Study ID

NCT03663530

Start date

Jan 1, 2019

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • <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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Meal times

Meal times vary based on the arm: aligned or misaligned

Primary outcome measure

  • Energy expenditure [ Time Frame: Change over 2-week period ]
  • Body composition [ Time Frame: Change over 4-week period ]
  • Nutritional intakes [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Diane Hawkins

212 305 9379dh3078@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Diane Hawkins

dh3078@cumc.columbia.edu

Principal Investigator:

Marie-Pierre St-Onge, PhD

More Information

Sponsor

Columbia University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Food intake
  • Energy expenditure
  • Body composition
  • Meal timing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-09.