Status:
COMPLETED
Daytime vs. Delayed Eating Among Obese Individuals
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
The randomized, cross-over design study is designed to determine how timing of eating affects weight, adiposity, energy metabolism, and gene expression. Obese participants will be provided isocaloric ...
Detailed Description
The study consists of the following phases - screening, assessment visit 1, eating condition 1, assessment visit 2, a wash-out period, assessment visit 3, eating condition 2 and assessment visit 4, as...
Eligibility Criteria
Inclusion
- age 21-50
- BMI of 30-50 kg/m2
- stable weight (±10 lb) over the previous 6 months
- women must be pre-menopausal with regular menstrual cycles
Exclusion
- unstable, serious medical conditions
- use of medicine linked to weight gain/loss
- cardiac conditions
- cancer
- diabetes
- autoimmune disease
- use of illicit drugs, melatonin, diuretics or hypnotics
- involved in a current weight loss program
- presence of an untreated sleep disorder (determined by surveys and actigraphy)
- those who work shift work
- those with extreme chronotypes
- habitual waking outside of 0600h-0930h
- habitual bedtime \<2200h or \>2400h
- sleep duration of \<6.5 or \>8.5 h/night.
- psychiatric exclusions will be: depression (Patient Health Questionnaire-9 score ≥9), lifetime bipolar disorder, psychosis, or eating disorder; or any other severe psychiatric disorder judged to interfere with study adherence as assessed by the MINI International Neuropsychiatric Interview.
- structured exercise \>3 d/wk, for \>30 min measured by exercise logs and actigraphy; normal activity levels are required during the study (±30 min/wk of baseline level).
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03354169
Start Date
February 7 2018
End Date
March 2 2023
Last Update
November 21 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