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Official title Circadian Misalignment and Energy Balance
ClinicalTrials.gov ID: NCT03663530
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 49. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- \<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)
See the full eligibility 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
- \<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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.