Human Plasma Fatty Acid Oscillations
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|ClinicalTrials.gov Identifier: NCT02502435|
Recruitment Status : Suspended (COVID-19)
First Posted : July 20, 2015
Last Update Posted : April 7, 2020
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.
|Condition or disease|
|Nocturnal Eating-Drinking Syndrome Healthy|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||Exploratory Phase I Study to Define Plasma Fatty Acid Oscillations in Patients With Night Eating Syndrome Compared to Healthy Volunteers.|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||July 2025|
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
Matched Healthy Controls
Healthy volunteers; 18-65 years of age; eating <25% of their caloric intake after dinner; no nocturnal ingestions
- Plasma fatty acids [ Time Frame: 64 hours ][% total fatty acid pool]
- Blood metabolite concentrations [ Time Frame: 64 hours ][uM]
- Core body temperature [ Time Frame: 64 hours ][degrees C]
- Bacterial taxa [ Time Frame: 64 hours ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502435
|United States, Pennsylvania|
|Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Georgios Paschos, PhD||University of Pennsylvania|
|Principal Investigator:||Kelly C Allison, PhD||University of Pennsylvania|
|Principal Investigator:||Garret A FitzGerald, MD||University of Pennsylvania|