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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02068001
Other study ID # NL45837.081.13
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 5, 2014
Last updated May 22, 2017
Start date July 2014

Study information

Verified date May 2017
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Roux-en-Y Gastric Bypass


Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland
Netherlands Gelderse Vallei Hospital Ede Gelderland
Netherlands Wageningen University Wageningen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Wageningen University Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Descriptives 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
Other Appetite ratings In a subset of 30 participants. During fMRI measurements, i.e., before and two months after surgery
Other Olfactory performance 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. At each fMRI measurement, i.e., before and two months after surgery
Other Development of BMI Before and after surgery
Primary Development of food preferences after Roux-en-Y gastric bypass surgery Food preferences will be assessed 2 weeks before Roux-en-Y Gastric Bypass surgery and 2 months, 1 year and 2 years after surgery. Participants will be followed for two years after they undergo surgery
Primary Change in brain reward response to food cues 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
Secondary Plasma levels of endocannabinoids and satiety hormones 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. Before and 2 months after surgery
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