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

Tracking Information

First Received Date ^ICMJE

February 6, 2012

Last Updated Date

September 28, 2012

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01531738 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Control
Normal weight healthy volunteers
Gastric banding
obese patients undergoing gastric banding obesity surgery
Gastric bypass
obese patients due to undergo gastric bypass surgery

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Alexander D Miras, MRCP

00442083831029

a.miras@nhs.net

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01531738

Other Study ID Numbers ^ICMJE

PRT

Has Data Monitoring Committee

Yes

Responsible Party

Carel Le Roux, Imperial College London

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Medical Research Council

Investigators ^ICMJE

Principal Investigator:

Carel W le Roux, MRCP PhD

Imperial College London

Information Provided By

Imperial College London

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top