Roux-en-Y Gastric BypassVerrukkelijkNCT02068001
Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery
An observational study of Roux-en-Y Gastric Bypass, run by Wageningen University at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Roux-en-Y Gastric Bypass
- What is being tested?
- Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jul 2014to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Morbidly obese individuals (age 18-55 years) scheduled for Roux-en-Y gastric bypass surgery at Rijnstate hospital, Arnhem
Who may be able to join
- Scheduled for Roux-en-Y Gastric Bypass Surgery at Rijnstate hospital
Who cannot join
- Lack of appetite
- Having difficulties swallowing/eating
- Being a vegetarian
- Allergic to food product used as stimuli in the study
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem, Gelderland, 6800 TA
Gelderse Vallei Hospital
Ede, Gelderland, 6716 RP
Wageningen University
Wageningen, Gelderland, 6700 EV
About this study
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.
- Conditions
- Roux-en-Y Gastric Bypass
- Being tested
- Roux-en-Y Gastric Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric BypassProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Roux-en-Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for two years after they undergo surgery
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.
Measured: Before and 2 months after surgery
Secondary outcomes (1)
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.
Measured: Before and 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Roux-en-Y Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Sponsor
- Investigators
- Suzanne EM de Bruijn, MSc, Principal investigator, Wageningen UniversityHarriët FA Zoon, MSc, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068001
- Sponsor's protocol ID
- NL45837.081.13
- Acronym
- Verrukkelijk
- Status last verified
- May 2017
- First submitted
- 5 Feb 2014
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02068001
- Acronym / sponsor ID
- Verrukkelijk / NL45837.081.13
- Conditions
- Roux-en-Y Gastric Bypass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- Jul 2014
- Primary completion
- Sep 2017 (estimated)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RYGB | – | Procedure: Roux-en-Y Gastric BypassFood preference assessment in 100 patients at different timepoints, in a subset of 30 participants, also brain reward response to food cues will be assessed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Morbidly obese individuals (age 18-55 years) scheduled for Roux-en-Y gastric bypass surgery at Rijnstate hospital, Arnhem
Key inclusion criteria (1 listed)
- Scheduled for Roux-en-Y Gastric Bypass Surgery at Rijnstate hospital
Key exclusion criteria (4 listed)
- Lack of appetite
- Having difficulties swallowing/eating
- Being a vegetarian
- Allergic to food product used as stimuli in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y Gastric Bypass | Procedure or surgery | RYGB |
Primary outcome
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.
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.
1 secondary outcome
Plasma levels of endocannabinoids and satiety hormones
Time frame: Before and 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne EM de Bruijn, MSc principal investigator
Wageningen University
Harriët FA Zoon, MSc principal investigator
Wageningen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Roux-en-Y Gastric Bypass, run by Wageningen University at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of food preferences after Roux-en-Y gastric bypass surgery (time frame: Participants will be followed for two years after they undergo surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.