ObesityNCT01531738
Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans
An observational study of Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to 1 Jan 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with obesity attending a specialist obesity clinic and normal weight controls who are staff at Imperial College London
Who may be able to join
- BMI of 18-25 for normal weight volunteers
- BMI of >30 for obese patients
Who cannot join
- Pregnancy
- breast feeding
- substance abuse
- consumption of more than 3 alcoholic units per day
- severe psychiatric illness
- lack of understanding of test instructions
Show all 10Show fewer
- diabetes mellitus
- chronic medical conditions making a general anaesthetic unsafe
- allergy to stimulus ingredients
- active smoking
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Weight Centre, Imperial College London
London, W6 8RF
About this study
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Taste, bariatric surgery, food preferences, reward, progressive ratio task
- Medical subject headings
- Obesity, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Normal weight healthy volunteers | |
| Bariatric Surgery | obese patients due to undergo gastric bypass or gastric banding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breakpoints as Assessed by Change in the Number of Mouse Clicks in the Last Completed Ratio
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.
Measured: 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
Secondary outcomes (2)
Hunger
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
Measured: 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
Body Mass Index
change in BMI will be quantified based on the participants weight in kilograms and height in meters
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJul 2010
- Primary completion1 Jan 2012
- Study completion1 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Carel Le Roux, Imperial College London
- Investigators
- Carel W le Roux, MRCP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531738
- Sponsor's protocol ID
- PRT
- Status last verified
- Oct 2020
- First submitted
- 6 Feb 2012
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 22836034
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans
- ClinicalTrials.gov ID
- NCT01531738
- Acronym / sponsor ID
- PRT
- Conditions
- Obesity
- Keywords
- Taste, bariatric surgery, food preferences, reward, progressive ratio task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Jul 2010
- Primary completion
- 1 Jan 2012 (actual)
- Study completion
- 1 Jan 2012 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Normal weight healthy volunteers |
| Bariatric Surgery | – | –obese patients due to undergo gastric bypass or gastric banding |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity attending a specialist obesity clinic and normal weight controls who are staff at Imperial College London
Key inclusion criteria (2 listed)
- BMI of 18-25 for normal weight volunteers
- BMI of >30 for obese patients
Key exclusion criteria (10 listed)
- Pregnancy
- breast feeding
- substance abuse
- consumption of more than 3 alcoholic units per day
- severe psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22836034Miras 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carel W le Roux, MRCP PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01531738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.