Night Eaters' blood fats under the microscope
NCT ID NCT02502435
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares the 24-hour rhythm of blood fats in people with night eating syndrome versus healthy volunteers. Researchers aim to see if unusual eating habits disrupt these rhythms. Only 12 participants are enrolled, and the study is currently suspended.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help explain why night eating syndrome occurs and point toward future treatments.
- What could go wrong
- This is a very small, early exploratory study with only 12 participants. It is currently suspended, so results may never be completed or may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2015
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with Night-Eating Syndrome: Participants have to meet both of the criteria for nocturnal ingestions and evening hyperphagia; eat 30% of their caloric intake after dinner with nocturnal wake ups to eat at a frequency of ≥ 5 times per week. Matching healthy participants: Participantswill be matched to a patient with Night-Eating Syndrome by gender, age and BMI.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Volunteers must be in good health as based on medical history, physical examination, vital signs, and laboratory tests as deemed by PI, BMI of 27-32; * Volunteers are capable of giving informed consent; * 18-65 years of age; * Non-smoking; and * Non-pregnant, female subjects must consent to a urine pregnancy test. * Control subjects eat less than 25% of their caloric intake after dinner without nocturnal ingestions; * NES patients have to meet both of the criteria for nocturnal ingestions and evening hyperphagia; eat 30% of their caloric intake after dinner with nocturnal wake ups to eat at a frequency of ≥ 5 times per week Exclusion Criteria: * Recent travel across time zones (within the past month); * Planned travel across time zones during the planned study activities; * Volunteers with irregular work hours, e.g. night shifts or swing shift schedule; * Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; * Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject; * Diagnosis of severe depression, lifetime diagnosis of bipolar disorder or any psychotic disorder; * Prescription and non-prescription (OTC) medication; medication with psychotropics (including hypnotics); * Actively participating in a weight loss diet or program; * Diagnosed with a different eating disorder; and lack of awareness of the night eating episodes (to differentiate from nocturnal sleep-related eating disorder, in which nocturnal eating is accompanied by a lack of awareness at the time and amnesia for the behavior the following day.) Exclusionary Medications and Substances * Subjects who have taken medications including antibiotics 2 weeks prior to the start of the study and throughout the study deemed by the investigator to interfere with the measurement of the study. Birth control pills are acceptable and will not be excluded; * Subjects who have taken aspirin or aspirin containing products for the 2 weeks prior to the start of the study and throughout the study; * Subjects who have taken acetaminophen, NSAIDS, COX-2 inhibitors (OTC or prescription) for 1 week prior to the start of the study and throughout the study; * Subjects who are currently consuming any type of tobacco product(s); * Use of recreational drugs within the last 6 months; * Subjects who consume high doses of antioxidant vitamins daily (vitamin C \> 1000mg, Vitamin E \> 400 IU, Beta Carotene \> 1000IU, Vitamin A \> 5000IU, Selenium \> 200mcg, Folic Acid \> 1mg) for the 2 weeks prior to the start of the study and throughout the study; * Subjects who consume caffeine or high fat food 72 hours prior to the start of each study visit; * Subjects need to abstain from alcohol consumption for 72 hours prior to the start of each study visit and throughout the active study. Contraindications for the use of ingestible Temperature Sensors: Screening for the contraindications listed below will occur during the physical and medical examination by a registered CTRC nurse or nurse practitioner: * In any patient whose body weight is less than eighty (80) pounds. * In the presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease. * In any patient exhibiting or having a history of disorders or impairment of the gag reflex. * In any patient with previous gastrointestinal surgery. * In any patient having fenilization of the esophagus. * In any patient who might undergo Nuclear Magnetic Resonance (NMR) or MRI scanning during the period that the CorTemp® Disposable Temperature Sensor is within the body. * In any patient with hypo motility disorders of the gastrointestinal tract including but not limited to Ileus. * In any patient having a cardiac pacemaker or other implanted electro medical device.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
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