Trial Outcomes & Findings for Investigation of the Effects of Bariatric Surgery on Taste Reward in Humans (NCT NCT01531738)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

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 posted on

2020-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Control Normal weight healthy volunteers	Bariatric Surgery obese patients due to undergo gastric bypass or gastric banding
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=11 Participants Normal weight healthy volunteers	Bariatric Surgery n=11 Participants obese patients due to undergo gastric bypass or gastric banding	Total n=22 Participants Total of all reporting groups
Age, Customized Age	39 years STANDARD_DEVIATION 5 • n=5 Participants	49 years STANDARD_DEVIATION 3 • n=7 Participants	44 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
BMI ("kg/m^2)	23 kg/m^2 STANDARD_DEVIATION 1 • n=5 Participants	48 kg/m^2 STANDARD_DEVIATION 2 • n=7 Participants	35.5 kg/m^2 STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=11 Participants Normal weight healthy volunteers	Bariatric Surgery n=11 Participants obese patients due to undergo gastric bypass or gastric banding
Breakpoints as Assessed by Change in the Number of Mouse Clicks in the Last Completed Ratio	0 Clicks Standard Deviation 40	320 Clicks Standard Deviation 30

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Control n=11 Participants Normal weight healthy volunteers	Bariatric Surgery n=11 Participants obese patients due to undergo gastric bypass or gastric banding
Hunger	20 mm Standard Deviation 30	-60 mm Standard Deviation 30

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control n=11 Participants Normal weight healthy volunteers	Bariatric Surgery n=11 Participants obese patients due to undergo gastric bypass or gastric banding
Body Mass Index	-0.2 kg/m^2 Standard Deviation 1.2	-6.2 kg/m^2 Standard Deviation 1.6

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bariatric Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carel le Roux

Imperial College

Phone: 07970719453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place