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NCT Number: NCT03663530

Circadian Misalignment and Energy Balance

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.

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Key information

Age range

20 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Diane Hawkins

CONTACT

[email protected]

Marie-Pierre St-Onge, PhD

PRINCIPAL_INVESTIGATOR

About this study

The proposed study will test whether the misalignment of eating occasions to the sleep period influences health markers. The goal of the proposed study is to determine whether eating out of synchrony with sleep influences risk of chronic diseases. The proposed study has both mechanistic and translational objectives. First, the investigators will test whether eating late in the day will influence energy balance (hormones, energy expenditure, nutritional intakes). Next, they will observe how misaligned meals, relative to aligned meals, influence behavior. Overweight men and women will be recruited to participate in a 2-phase, crossover study, with constant sleep periods. Phases will only differ in the alignment of meals to the sleep period: aligned = meals starting 1 h after awakening; misaligned = meals starting 5 h after awakening. Mechanistic aims will be addressed from measurements taken after 3 and 14 d of the intervention. The translational aim will be addressed after a 4 wk free-living period following the prescribed meal times for each phase. This proposed study, which will manipulate meal timing, without affecting total sleep time, is important because it will provide information on the mechanism by which circadian misalignment influences health. As such, the proposed study will be a stepping-stone in the establishment of lifestyle recommendations or therapies to personalize chronotype to reduce the risk of chronic diseases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal times

Behavioral

Meal times vary based on the arm: aligned or misaligned

Primary outcomes

  1. Energy expenditure

    Time frame: Change over 2-week period

    Metabolic chamber

  2. Body composition

    Time frame: Change over 4-week period

    Quantitative magnetic resonance

  3. Nutritional intakes

    Time frame: 4 weeks

    3-day food records

Secondary outcomes

  1. Task-based functional neuroimaging

    Time frame: Change over 2-week period

    Brain responses to food stimuli

  2. Resting state functional neuroimaging

    Time frame: Change over 2-week period

    Functional neuroimaging

  3. Appetite

    Time frame: 4 weeks

    Visual analog scales

  4. Hormones

    Time frame: Change over 2-week period

    Leptin, ghrelin, peptide tyrosine tyrosine, glucagon-like peptide 1

Other outcomes

  1. Circadian rhythms

    Time frame: Change over 2-week period

    Melatonin and cortisol

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Hawkins

CONTACT

[email protected]

212 305 9379

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • NYU Langone Health

Registry information

Official study title

Impact of Circadian Misalignment on Energy Balance Regulation

Acronym: CM

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2018
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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