Actively Recruiting
Circadian Misalignment and Energy Balance
Led by Columbia University · Updated on 2025-09-09
42
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
NYU Langone Health
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Circadian Misalignment and Energy Balance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All racial and ethnic groups
- Body mass index 20-34.9 kg/m2
- Average sleep duration 657 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
You will not qualify if you...
- Less than 10 nights of sleep under 7 hours during the 2-week screening period
- Daytime napping
- Current or past sleep disorder; Insomnia Severity Index Score over 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 or use of tobacco products, e-cigarettes, vapes, or ex-smoker less than 3 years
- Night and rotating shift work
- Travel across time zones within 4 weeks of the study
- History of drug or alcohol abuse or excessive alcohol consumption (more than 3 drinks/day for men or 2 for women)
- Recent weight change over 5% gain or loss in past 3 months or active diet/weight loss program in previous 3 months; any weight loss procedure
- Pregnancy or less than 1 year post-partum
- Diagnosed sleep apnea or high-risk score on Berlin questionnaire
- Depression (score over 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 below 30%
- Taking beta blockers, as this can interfere with melatonin secretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
D
Diane Hawkins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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