Nocturnal Eating-Drinking SyndromeNCT02502435
Human Plasma Fatty Acid Oscillations
An observational study of Nocturnal Eating-Drinking Syndrome and Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study wishes to look at the 24-hour rhythm of certain fats in the blood stream. Recent studies in animals and healthy participants suggest that unusual eating habits may be connected to a change in the 24-hour rhythm of the blood fats the investigators wish to measure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Eating-Drinking Syndrome, Healthy
- What is being tested?
- Observation
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Exploratory Phase I Study to Define Plasma Fatty Acid Oscillations in Patients With Night Eating Syndrome Compared to Healthy Volunteers.
This study wishes to look at the 24-hour rhythm of certain fats in the blood stream. Recent studies in animals and healthy participants suggest that unusual eating habits may be connected to a change in the 24-hour rhythm of the blood fats the investigators wish to measure. The investigators will ask persons suffering from night eating syndrome, a condition where people eat additional meals throughout the night, to participate in this study. Healthy volunteers who are of the same age and gender, and have a comparable body-mass-index, a number calculated from a person's weight and height, will also be asked to participate.
The aim is to learn how the 24-hour rhythm of the blood fats the investigators measure differs between the persons experiencing the night eating episodes and persons who do not.
Read the detailed description
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.
- Conditions
- Nocturnal Eating-Drinking Syndrome, Healthy
- Being tested
- Observation
- Medical subject headings
- Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with Night-Eating Syndrome | Individuals diagnosed with Night Eating Syndrome (NES); 18-65 years of age; eating 30% of their caloric intake after dinner with nocturnal awakenings to eat at a frequency of ≥ 5 times per week Receives: Other: Observation | |
| Matched Healthy Controls | Healthy volunteers; 18-65 years of age; eating <25% of their caloric intake after dinner; no nocturnal ingestions Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma fatty acids
[% total fatty acid pool]
Measured: 64 hours
Secondary outcomes (3)
Blood metabolite concentrations
[uM]
Measured: 64 hours
Core body temperature
[degrees C]
Measured: 64 hours
Bacterial taxa
The proportions of the genus "Firmicutes Streptococcus" differences between mornings (0, 24, 48 hours) versus evenings (12, 36 hours) in microbiota collected by oral swabs from the left and right cheek.
Measured: 64 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2027 (estimated)
- Study completionJul 2028 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal Eating-Drinking SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Skarke, MD, University of Pennsylvania
- Investigators
- Georgios Paschos, PhD, Principal investigator, University of PennsylvaniaKelly C Allison, PhD, Principal investigator, University of PennsylvaniaGarret A FitzGerald, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502435
- Sponsor's protocol ID
- 819453
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2015
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Phase I Study to Define Plasma Fatty Acid Oscillations in Patients With Night Eating Syndrome Compared to Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02502435
- Acronym / sponsor ID
- 819453
- Conditions
- Nocturnal Eating-Drinking Syndrome, Healthy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study wishes to look at the 24-hour rhythm of certain fats in the blood stream. Recent studies in animals and healthy participants suggest that unusual eating habits may be connected to a change in the 24-hour rhythm of the blood fats the investigators wish to measure. The investigators will ask persons suffering from night eating syndrome, a condition where people eat additional meals throughout the night, to participate in this study. Healthy volunteers who are of the same age and gender, and have a comparable body-mass-index, a number calculated from a person's weight and height, will also be asked to participate.
The aim is to learn how the 24-hour rhythm of the blood fats the investigators measure differs between the persons experiencing the night eating episodes and persons who do not.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Night-Eating Syndrome | – | Other: ObservationIndividuals diagnosed with Night Eating Syndrome (NES); 18-65 years of age; eating 30% of their caloric intake after dinner with nocturnal awakenings to eat at a frequency of ≥ 5 times per week |
| Matched Healthy Controls | – | Other: ObservationHealthy volunteers; 18-65 years of age; eating <25% of their caloric intake after dinner; no nocturnal ingestions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservational study | Other | Matched Healthy Controls, Patients with Night-Eating Syndrome |
Primary outcome
Plasma fatty acids
Time frame: 64 hours
[% total fatty acid pool]
3 secondary outcomes
Blood metabolite concentrations
Time frame: 64 hours
Core body temperature
Time frame: 64 hours
Bacterial taxa
Time frame: 64 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Center for Weight and Eating DisordersLink provided by the sponsor.
- FitzGerald LabLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Paschos, PhD principal investigator
University of Pennsylvania
Kelly C Allison, PhD principal investigator
University of Pennsylvania
Garret A FitzGerald, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Eating-Drinking Syndrome and Healthy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma fatty acids (time frame: 64 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.