NCT03663530Active, not recruiting
Circadian Misalignment and Energy Balance
Impact of Circadian Misalignment on Energy Balance Regulation
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 5 Sept 2018
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Columbia University
- Diseases
- Obesity
- NCT number
- NCT03663530
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 1 Jan 2019 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Depression (score \>13 on Beck Depression Inventory II) or taking anti-depressive medications
- Taking psychoactive or hypnotic medications
- Taking chronic analgesic or anti-inflammatory medications
- Having had gastrointestinal surgery, including gastric bypass surgery
Other illness
- 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
- History of drug or alcohol abuse or excessive alcohol consumption (\>3 drinks/day for men or 2 for women)
- Restless leg syndrome and circadian rhythm disorders
- Dementia or cognitive impairments
Age
- Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers \<3 years)
Other
- \<10 nights of sleep \<7 hour during the 2-week screening period
- Daytime napping
- Night and rotating shift work
- Travel across time zones within 4 wk of the study
- Pregnancy or \<1 year post-partum
- Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score)
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 49 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.