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

This study is currently recruiting participants.
Verified September 2012 by Imperial College London
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London
ClinicalTrials.gov Identifier:
NCT01531738
First received: February 6, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Breakpoints [ 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 ] [ Designated as safety issue: No ]
    Change in breakpoints in the last completed ratio of the computer task (breakpoints reflect the affective value of the reinforcer used)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    change in hunger levels quantified by a 100mm visual analogue scale

  • 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 ] [ Designated as safety issue: No ]
    change in BMI will be quantified based on the participants weight in kilograms and height in meters


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Normal weight healthy volunteers
Gastric banding
obese patients undergoing gastric banding obesity surgery
Gastric bypass
obese patients due to undergo gastric bypass surgery

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531738

Contacts
Contact: Alexander D Miras, MRCP 00442083831029 a.miras@nhs.net

Locations
United Kingdom
Imperial Weight Centre, Imperial College London Recruiting
London, United Kingdom, W6 8RF
Contact: Alexander D Miras, MRCP     00442083831029     a.miras@nhs.net    
Sub-Investigator: Robert N Jackson, MSc            
Sponsors and Collaborators
Imperial College London
Medical Research Council
Investigators
Principal Investigator: Carel W le Roux, MRCP PhD Imperial College London
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carel Le Roux, Principal Investigator, Imperial College London
ClinicalTrials.gov Identifier: NCT01531738     History of Changes
Other Study ID Numbers: PRT
Study First Received: February 6, 2012
Last Updated: September 28, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Taste
bariatric surgery
food preferences
reward
progressive ratio task

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013