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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01531738 |
|
Recruitment Status
:
Recruiting
First Posted
: February 13, 2012
Last Update Posted
: November 2, 2016
|
Sponsor:
Imperial College London
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
| Estimated Enrollment : | 20 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 |
| Estimated Primary Completion Date : | August 2018 |
| Estimated Study Completion Date : | August 2018 |
| Group/Cohort |
|---|
|
Control
Normal weight healthy volunteers
|
|
Gastric banding
obese patients undergoing gastric banding obesity surgery
|
|
Gastric bypass
obese patients due to undergo gastric bypass surgery
|
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 ]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 ]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 ]change in BMI will be quantified based on the participants weight in kilograms and height in meters
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.
| Ages Eligible for Study: | 18 Years to 65 Years (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
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
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 |
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 |
| First Posted: | February 13, 2012 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | November 2016 |
| 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 |