Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT02502435
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02502435
Study Brief:
Protocol Section:
NCT02502435