- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01531738
Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans
October 22, 2020 updated by: Carel Le Roux, Imperial College London
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 Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
22
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
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London, United Kingdom, W6 8RF
- Imperial Weight Centre, Imperial College London
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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
Description
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
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
Cohorts and Interventions
Group / Cohort |
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Control
Normal weight healthy volunteers
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Bariatric Surgery
obese patients due to undergo gastric bypass or gastric banding
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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 weeks pre and 8-12 weeks post operatively for surgical patients or on two occasions 10-14 weeks apart for normal weight control group
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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
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change in BMI will be quantified based on the participants weight in kilograms and height in meters
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carel W le Roux, MRCP PhD, Imperial College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 6, 2012
First Submitted That Met QC Criteria
February 8, 2012
First Posted (Estimate)
February 13, 2012
Study Record Updates
Last Update Posted (Actual)
November 16, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- PRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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