Status:
COMPLETED
Randomized Study of Daytime vs. Delayed Eating: Effect on Weight and Metabolism
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Conditions:
Obesity
Eligibility:
All Genders
21-45 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if, controlling for eating and sleep timing, caloric intake, and exercise, daytime vs. delayed eating affects body mass, adiposity, and energy metabolism in h...
Detailed Description
The study consists of 4 phases - screening \& baseline assessment, eating condition 1, wash-out period, and eating condition 2. Before and after each phase participants will complete a 28-hour inpatie...
Eligibility Criteria
Inclusion
- Adults of all races and ethnicities
- Age 21-45; BMI 20-27 kg/m2
- stable weight (+/- 10 lbs) over the previous 6 months
- Women must be pre-menopausal with regular menstrual cycles.
Exclusion
- Regular exercise more than 3 d/wk, for 30 min measured by exercise logs and actigraphy
- normal activity levels are required throughout the study (+/-30 min/wk of baseline level).
- Unstable, serious medical conditions
- use of medicine linked to weight gain/loss
- cancer, diabetes, or autoimmune disease
- use of illicit drugs, melatonin, diuretics or hypnotics
- current weight loss program; presence of a sleep disorder (determined by surveys and actigraphy)
- night shift work; extreme chronotypes (extreme larks or night owls)
- habitual waking outside of 0600 h-0930h
- habitual bedtime outside of 2200h to 2400h
- sleep duration outside of 6.5 to 8.5 h/night.
- Psychiatric exclusions will be depression (Patient Health Questionnaire-9 score 9), lifetime bipolar disorder, psychosis, or lifetime eating disorder; or any other severe psychiatric disorder judged to interfere with study adherence as assessed by the Structured Clinical Interview for the DSM-IV.
Key Trial Info
Start Date :
October 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04414644
Start Date
October 8 2014
End Date
June 5 2017
Last Update
March 11 2025
Active Locations (1)
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1
Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104