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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2016 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: February 26, 2016

Last verified: February 2016

History of Changes

Purpose

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:

MedlinePlus related topics: Taste and Smell Disorders Weight Loss Surgery

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 2018
Estimated Primary Completion Date:	August 2018 (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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
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

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, see Learn About Clinical Studies.

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

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

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.


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:	February 26, 2016
Health Authority:	United Kingdom: Research Ethics Committee
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Imperial College London:


Taste bariatric surgery food preferences reward progressive ratio task

ClinicalTrials.gov processed this record on September 23, 2016

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