Human Plasma Fatty Acid Oscillations

NCT02502435 | Suspended

• 1 other identifier: 819453
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nocturnal Eating-Drinking Syndrome; Healthy

Outcome Measures

Primary Outcomes (1)

• Plasma fatty acids

  \[% total fatty acid pool\]

  64 hours

Secondary Outcomes (3)

• Blood metabolite concentrations

  64 hours

• Core body temperature

  64 hours

• Bacterial taxa

  64 hours

Study Arms (2)

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

Other: Observation

Matched Healthy Controls

Healthy volunteers; 18-65 years of age; eating \<25% of their caloric intake after dinner; no nocturnal ingestions

Other: Observation

Interventions

Observation OTHER

Observational study

Matched Healthy Controls; Patients with Night-Eating Syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.)
• 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;

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Center for Weight and Eating Disorders
• FitzGerald Lab

Biospecimen

Retention: SAMPLES WITH DNA

Genetic analysis will be performed using High Throughput Sequencing (HTS) technology.

MeSH Terms

Conditions

Dyssomnias

Interventions

Observation

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Georgios Paschos, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Kelly C Allison, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Garret A FitzGerald, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)