Circadian Misalignment and Energy Balance

Launched by COLUMBIA UNIVERSITY · Sep 6, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how the timing of meals and sleep affects body weight and energy balance, particularly in people who may have irregular sleep patterns, like shift workers or those dealing with jet lag. Researchers believe that when meal times and sleep times are out of sync, it may change how our brains process food and hunger signals. This study aims to better understand these effects, which could help develop helpful advice for managing weight through better meal and sleep timing.

To participate in the trial, individuals must be between 18 and 65 years old, have a body mass index (BMI) between 20 and 34.9, and typically sleep at least 7 hours a night. Participants should also eat breakfast within an hour of waking up at least five days a week, and their sleep should generally end by 4 AM or earlier. Those who qualify can expect to engage in assessments over a two-week period to determine their eligibility and contribute to important research that could benefit others facing similar challenges with weight and sleep.

Gender

ALL

Eligibility criteria

• 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