NCT02068001

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

February 5, 2014

Last Update Submit

May 22, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Plasma levels of endocannabinoids and satiety hormones

    Before and 2 months after surgery

Other Outcomes (4)

  • Descriptives

    Before surgery

  • Appetite ratings

    During fMRI measurements, i.e., before and two months after surgery

  • Olfactory performance

    At each fMRI measurement, i.e., before and two months after surgery

  • +1 more other outcomes

Study Arms (1)

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

Interventions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Morbidly obese individuals (age 18-55 years) scheduled for Roux-en-Y gastric bypass surgery at Rijnstate hospital, Arnhem

You may qualify if:

  • Scheduled for Roux-en-Y Gastric Bypass Surgery at Rijnstate hospital

You may not qualify if:

  • Lack of appetite
  • Having difficulties swallowing/eating
  • Being a vegetarian
  • Allergic to food product used as stimuli in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Gelderse Vallei Hospital

Ede, Gelderland, 6716 RP, Netherlands

Location

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

Location

MeSH Terms

Interventions

Gastric Bypass

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Suzanne EM de Bruijn, MSc

    Wageningen University

    PRINCIPAL INVESTIGATOR
  • Harriët FA Zoon, MSc

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 20, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations