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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800 TA
        • Rijnstate Hospital
      • Ede, Gelderland, Netherlands, 6716 RP
        • Gelderse Vallei Hospital
      • Wageningen, Gelderland, Netherlands, 6700 EV
        • Wageningen University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Roux-en-Y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
Change in brain reward response to food cues
Time Frame: Before and 2 months after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma levels of endocannabinoids and satiety hormones
Time Frame: Before and 2 months after surgery
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Descriptives
Time Frame: Before surgery

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
Appetite ratings
Time Frame: During fMRI measurements, i.e., before and two months after surgery
In a subset of 30 participants.
During fMRI measurements, i.e., before and two months after surgery
Olfactory performance
Time Frame: At each fMRI measurement, i.e., before and two months after surgery
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
Development of BMI
Time Frame: Before and after surgery
Before and after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rijnstate Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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