Circadian Misalignment and Energy Balance
Recruiting · NCT03663530 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Columbia University Irving Medical Center - New York, New York, United States