Obesity, Morbid Clinical Trial
Official title:
Microstructural Analysis of Ingestive Behavior After Roux-en-Y Gastric Bypass - a Prospective Controlled Exploratory Pilot Study Using a Novel Drinkometer to Measure Liquid Lunch Intake
Verified date | June 2021 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The ability to assess ingestion in fine detail over the time course of a liquid meal allows for comparison of early and late meal features of drinking and may help dissociate manipulations (surgical, neural, pharmacological, etc.) that affect orosensory properties from those that are modulating postoral processes in the control of intake. The aim of the study is to asses microstructural changes in liquid meal intake over 1-year in severely obese patients after Roux-en-Y gastric bypass (RYGB).
Status | Completed |
Enrollment | 30 |
Est. completion date | September 30, 2020 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - ability to provide inform consent - treatment group: scheduled for RYGB for severe obesity - control group: normal weight, healthy general condition Exclusion Criteria: - lactose intolerance - diabetes - immunosuppression - pregnancy / lactation - use of weight-loss medication |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zürich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Marco Bueter | Department of Psychology and Program in Neuroscience, Florida State University, Tallahassee, FL, USA |
Switzerland,
Gero D, File B, Justiz J, Steinert RE, Frick L, Spector AC, Bueter M. Drinking microstructure in humans: A proof of concept study of a novel drinkometer in healthy adults. Appetite. 2019 Feb 1;133:47-60. doi: 10.1016/j.appet.2018.08.012. Epub 2018 Sep 1. — View Citation
Gero D, Steinert RE, le Roux CW, Bueter M. Do Food Preferences Change After Bariatric Surgery? Curr Atheroscler Rep. 2017 Sep;19(9):38. doi: 10.1007/s11883-017-0674-x. Review. — View Citation
Johnson AW. Characterizing ingestive behavior through licking microstructure: Underlying neurobiology and its use in the study of obesity in animal models. Int J Dev Neurosci. 2018 Feb;64:38-47. doi: 10.1016/j.ijdevneu.2017.06.012. Epub 2017 Jul 3. Review. — View Citation
Mathes CM, Bohnenkamp RA, Blonde GD, Letourneau C, Corteville C, Bueter M, Lutz TA, le Roux CW, Spector AC. Gastric bypass in rats does not decrease appetitive behavior towards sweet or fatty fluids despite blunting preferential intake of sugar and fat. Physiol Behav. 2015 Apr 1;142:179-88. doi: 10.1016/j.physbeh.2015.02.004. Epub 2015 Feb 3. — View Citation
Spector AC, Klumpp PA, Kaplan JM. Analytical issues in the evaluation of food deprivation and sucrose concentration effects on the microstructure of licking behavior in the rat. Behav Neurosci. 1998 Jun;112(3):678-94. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in microstructure of ingestive behavior of 1 liquid meal | recording of meal intake by the drinkometer | baseline, 1 week, 1-3-6-12 months | |
Secondary | change in self-reported hunger, thirst, fullness, taste preference, estimated consumption | visual analogue scale (0-100 mm, higher number refer to stronger feeling/higher liking) | baseline, 1 week, 1-3-6-12 months | |
Secondary | body mass index | weight/height measurements | baseline, 1 week, 1-3-6-12 months |
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