- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068001
Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery (Verrukkelijk)
May 22, 2017 updated by: Wageningen University
It has been suggested that obese people are more sensitive to sensory and rewarding effects of food, aspects that mediate food preferences and intake.
Individuals that underwent Roux-en-Y gastric bypass surgery frequently report changes in food preference.
They indicate a decreased preference for highly rewarding energy dense foods.
Changes in food preference might be related to alterations in central (brain) mechanisms, related to reward sensing.
The smell and sight of food can be considered as anticipatory cues for the rewarding effects of food intake.
The aim of this study is to determine the effect of gastric bypass surgery on (alterations in) food preferences.
Secondly, this study aims at assessing the effect of gastric bypass surgery on the brain reward response when exposed to sight and smell of food stimuli with different sugar and fat contents.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gelderland
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Arnhem, Gelderland, Netherlands, 6800 TA
- Rijnstate Hospital
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Ede, Gelderland, Netherlands, 6716 RP
- Gelderse Vallei Hospital
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Wageningen, Gelderland, Netherlands, 6700 EV
- Wageningen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 51 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Morbidly obese individuals (age 18-55 years) scheduled for Roux-en-Y gastric bypass surgery at Rijnstate hospital, Arnhem
Description
Inclusion Criteria:
- Scheduled for Roux-en-Y Gastric Bypass Surgery at Rijnstate hospital
Exclusion Criteria:
- Lack of appetite
- Having difficulties swallowing/eating
- Being a vegetarian
- Allergic to food product used as stimuli in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
RYGB
Food preference assessment in 100 patients at different timepoints, in a subset of 30 participants, also brain reward response to food cues will be assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of food preferences after Roux-en-Y gastric bypass surgery
Time Frame: Participants will be followed for two years after they undergo surgery
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Food preferences will be assessed 2 weeks before Roux-en-Y Gastric Bypass surgery and 2 months, 1 year and 2 years after surgery.
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Participants will be followed for two years after they undergo surgery
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Change in brain reward response to food cues
Time Frame: Before and 2 months after surgery
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Two weeks before and two months after Roux-en-Y Gastric Bypass the brain reward response to the sight and smell of food will be assessed in a subset of 30 participants.
|
Before and 2 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma levels of endocannabinoids and satiety hormones
Time Frame: Before and 2 months after surgery
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Two weeks before and two months after Roux-en-Y gastric bypass surgery, fasted plasma levels of endocannabinoids, ghrelin, leptin, adiponectin and Glucagon-Like Peptide will be assessed in a subset of 30 participants.
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Before and 2 months after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Descriptives
Time Frame: Before surgery
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General subject characteristics, e.g. age, gender, restrained eating score and other lifestyle and medical parameters. For the subset of 30 patients that participate in the fMRI measurements: disinhibition scores will be assessed. |
Before surgery
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Appetite ratings
Time Frame: During fMRI measurements, i.e., before and two months after surgery
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In a subset of 30 participants.
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During fMRI measurements, i.e., before and two months after surgery
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Olfactory performance
Time Frame: At each fMRI measurement, i.e., before and two months after surgery
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The Sniffin' Sticks test will be used to assess olfactory performance in the subset of 30 participants that will participate in the fMRI measurements.
The sum-score of threshold, discrimination and identification tests will be used to determine if a participant is normosmic.
A score of > 30 indicates a participant is normosmic.
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At each fMRI measurement, i.e., before and two months after surgery
|
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Development of BMI
Time Frame: Before and after surgery
|
Before and after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne EM de Bruijn, MSc, Wageningen University
- Principal Investigator: Harriët FA Zoon, MSc, Wageningen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
February 5, 2014
First Submitted That Met QC Criteria
February 17, 2014
First Posted (Estimate)
February 20, 2014
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 22, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- NL45837.081.13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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