NCT03663530 · Columbia University
Circadian Misalignment and Energy Balance
(CM)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Meal times
Meal times vary based on the arm: aligned or misaligned
Primary outcome measures
Energy expenditure
Time frame: Change over 2-week period
Metabolic chamber
Body composition
Time frame: Change over 4-week period
Quantitative magnetic resonance
Nutritional intakes
Time frame: 4 weeks
3-day food records
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
NYU Langone Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations