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.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 1 January 2019
🗓️ Primary Completion (Estimated) 31 July 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 42
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 20 Years to 49 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 September 2018
  • First Submitted that Met QC Criteria 6 September 2018
  • First Posted 10 September 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 March 2024
  • Last Update Posted 1 April 2024
  • Last Verified March 2024