Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531738
Recruitment Status : Completed
First Posted : February 13, 2012
Results First Posted : October 22, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Obesity

Detailed Description:
Severe obesity is associated with excessive food eating and appetite. Bariatric surgery (also known as 'obesity surgery' or 'weight loss surgery') is a well known treatment for severely obese individuals. The way in which these operations achieve weight loss is not fully understood. 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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans
Study Start Date : July 2010
Actual Primary Completion Date : January 1, 2012
Actual Study Completion Date : January 1, 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Control
Normal weight healthy volunteers
Bariatric Surgery
obese patients due to undergo gastric bypass or gastric banding


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Breakpoints as Assessed by Change in the Number of Mouse Clicks in the Last Completed Ratio [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Hunger [ Time Frame: 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 ]

    Visual Analogue Scale ratings of hunger. The scale is 100mm line with two anchors at each end. Scores are recorded by making a handwritten mark that represents a continuum between "not hungry at all" and "Extremely hungry." The score of 0 represents least hunger. The score of 100 represents extreme hunger.

    change in hunger levels quantified by a 100mm visual analogue scale


  2. Body Mass Index [ Time Frame: 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 ]
    change in BMI will be quantified based on the participants weight in kilograms and height in meters


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with obesity attending a specialist obesity clinic and normal weight controls who are staff at Imperial College London
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531738


Locations
Layout table for location information
United Kingdom
Imperial Weight Centre, Imperial College London
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Medical Research Council
Investigators
Layout table for investigator information
Principal Investigator: Carel W le Roux, MRCP PhD Imperial College London
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Carel Le Roux, Principal Investigator, Imperial College London
ClinicalTrials.gov Identifier: NCT01531738    
Other Study ID Numbers: PRT
First Posted: February 13, 2012    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: November 16, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carel Le Roux, Imperial College London:
Taste
bariatric surgery
food preferences
reward
progressive ratio task