Human Plasma Fatty Acid Oscillations

A disease mechanism driving the clinical symptomology of the Night Eating Syndrome (NES) may
be a metabolome, polyunsaturated fatty acids in particular, disrupted in its oscillations
throughout the course of day and night. Blood and stool samples will be repeatedly taken
during a 3-night/2-day protocol from NES patients and healthy controls with lights dimmed to
20 lux and time cues removed. Body core temperature and physical activity during the study
will be monitored continuously.

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.