NCT01531738

Brief Summary

The investigators hypothesize that some of these changes in the reduced appetite after surgery may be due to alterations in taste. The aim is to compare obese patients before and after bariatric surgery (gastric bypass and banding) to define the reward value of sweet, fatty and vegetable/fruit taste in obese individuals, and how this changes after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

October 22, 2020

Completed
Last Updated

November 16, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

February 6, 2012

Results QC Date

August 17, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

Tastebariatric surgeryfood preferencesrewardprogressive ratio task

Outcome Measures

Primary Outcomes (1)

  • Breakpoints as Assessed by Change in the Number of Mouse Clicks in the Last Completed Ratio

    Patients were placed in front of a computer screen and a plate of 20 chocolate candies. The following prompt appeared on the screen: "You can earn food by clicking on the mouse button. Click as much or as little as you like. When you no longer want to continue, press the spacebar to stop the session."Upon completion of each ratio a message box appeared on the screen: "You have earned food. Enjoy your reward and after you have swallowed it completely you may click on OK to continue with the programme."After ingesting the reward, the patients pressed the OK button in the message box only if they wished to progress to the next ratio to obtain another chocolate candy. The starting ratio was 10 clicks with a geometric increment of 2 (i.e., 10, 20, 40, 80, and so on). When the effort of pressing the mouse button was greater than the rewarding value of the chocolate candy, patients pressed on the space bar to terminate the session. This indicated that the breakpoint was reached.

    2 weeks pre and 8-12 weeks post operatively for surgical patients or on two occasions 10-14 weeks apart for normal weight control group

Secondary Outcomes (2)

  • Hunger

    2 weeks pre and 8-12 weeks post operatively for surgical patients or on two occasions 10-14 weeks apart for normal weight control group

  • Body Mass Index

    2 weeks pre and 8-12 weeks post operatively for surgical patients or on two occasions 10-14 weeks apart for normal weight control group

Study Arms (2)

Control

Normal weight healthy volunteers

Bariatric Surgery

obese patients due to undergo gastric bypass or gastric banding

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with obesity attending a specialist obesity clinic and normal weight controls who are staff at Imperial College London

You may qualify if:

  • BMI of 18-25 for normal weight volunteers
  • BMI of \>30 for obese patients

You may not qualify if:

  • Pregnancy
  • breast feeding
  • substance abuse
  • consumption of more than 3 alcoholic units per day
  • severe psychiatric illness
  • lack of understanding of test instructions
  • diabetes mellitus
  • chronic medical conditions making a general anaesthetic unsafe
  • allergy to stimulus ingredients
  • active smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Weight Centre, Imperial College London

London, W6 8RF, United Kingdom

Location

Related Publications (1)

  • Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.

MeSH Terms

Conditions

ObesityFood Preferences

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Results Point of Contact

Title
Carel le Roux
Organization
Imperial College

Study Officials

  • Carel W le Roux, MRCP PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 13, 2012

Study Start

July 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 16, 2020

Results First Posted

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations