Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 4:07 AM
Study NCT ID:
NCT02502435
Status:
SUSPENDED
Last Update Posted:
2025-01-17
First Post:
2015-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Plasma Fatty Acid Oscillations
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Exploratory Phase I Study to Define Plasma Fatty Acid Oscillations in Patients With Night Eating Syndrome Compared to Healthy Volunteers.
Status:
SUSPENDED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: