Trial Outcomes & Findings for Taste Perception Pre and Post Bariatric Surgery (NCT NCT01536197)
NCT ID: NCT01536197
Last Updated: 2017-12-18
Results Overview
-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
Recruitment status
COMPLETED
Target enrollment
33 participants
Primary outcome timeframe
we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery
Results posted on
2017-12-18
Participant Flow
Participant milestones
| Measure |
Gastric Bypass
morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass
|
Gastric Banding
morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
10
|
|
Overall Study
COMPLETED
|
23
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Taste Perception Pre and Post Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Gastric Bypass
n=23 Participants
morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass
|
Gastric Banding
n=10 Participants
morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body weight before surgery
|
129.8 Kg
STANDARD_DEVIATION 26.1 • n=5 Participants
|
127.1 Kg
STANDARD_DEVIATION 31.0 • n=7 Participants
|
128.7 Kg
STANDARD_DEVIATION 27.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
Outcome measures
| Measure |
Gastric Bypass
n=23 Participants
morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass
|
Gastric Banding
n=10 Participants
morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding
|
|---|---|---|
|
Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).
Sucrose taste detection threshold before surgery
|
7.5 mmol/L
Interval 2.4 to 12.6
|
8.1 mmol/L
Interval 6.5 to 11.5
|
|
Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).
Sucrose taste detection threshold after surgery
|
6.5 mmol/L
Interval 4.6 to 8.4
|
7.5 mmol/L
Interval 4.9 to 13.4
|
SECONDARY outcome
Timeframe: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Craving Inventory (FCI). The DEBQ measures three common psychological dimensions of eating behavior: 1) emotional eating , 2) external eating (an inclination to eat in response to external food cues such as the smell and taste of food), and 3) restrained eating (an inclination to consciously restrict food intake to control body weight). The FCI is a validated measure of the frequency of overall food cravings as well as cravings for specific types of foods (high fats, sweets, carbohydrates/ starches, and fast-food fats) during the past month. For the DEBQ and the FCI, subjects score their answers by using a 5-point Likert scale (1=never, 5=very often/always).Therefore, lower numbers means having less frequent food cravings (for FCI), or engaging less frequently in the particular type of eating behavior (for DEBQ).
Outcome measures
| Measure |
Gastric Bypass
n=23 Participants
morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass
|
Gastric Banding
n=10 Participants
morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding
|
|---|---|---|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for sweets before surgery
|
2.3 units on a scale
Standard Deviation 0.8
|
2.7 units on a scale
Standard Deviation 0.7
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for sweets after surgery
|
1.6 units on a scale
Standard Deviation 0.6
|
2.3 units on a scale
Standard Deviation 0.5
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for fast food before surgery
|
2.9 units on a scale
Standard Deviation 0.7
|
2.6 units on a scale
Standard Deviation 0.8
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for fast food after surgery
|
2.2 units on a scale
Standard Deviation 0.6
|
2.2 units on a scale
Standard Deviation 0.5
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for high fat food before surgery
|
2.2 units on a scale
Standard Deviation 0.7
|
2.0 units on a scale
Standard Deviation 0.8
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for high fat food after surgery
|
1.8 units on a scale
Standard Deviation 0.6
|
1.9 units on a scale
Standard Deviation 0.7
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for starchy food before surgery
|
2.2 units on a scale
Standard Deviation 0.8
|
2.2 units on a scale
Standard Deviation 0.5
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Cravings for starchy food after surgery
|
1.9 units on a scale
Standard Deviation 0.7
|
1.9 units on a scale
Standard Deviation 0.6
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Restrained eating before surgery
|
2.9 units on a scale
Standard Deviation 0.6
|
2.8 units on a scale
Standard Deviation 0.5
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Restrained eating after surgery
|
3.0 units on a scale
Standard Deviation 0.7
|
3.4 units on a scale
Standard Deviation 1
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Emotional eating before surgery
|
2.6 units on a scale
Standard Deviation 0.9
|
3.2 units on a scale
Standard Deviation 1.0
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Emotional eating after surgery
|
1.8 units on a scale
Standard Deviation 0.7
|
2.3 units on a scale
Standard Deviation 1.0
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
External eating before surgery
|
3.0 units on a scale
Standard Deviation 0.5
|
3.4 units on a scale
Standard Deviation 0.5
|
|
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
External eating after surgery
|
2.2 units on a scale
Standard Deviation 0.5
|
2.4 units on a scale
Standard Deviation 0.6
|
Adverse Events
Gastric Bypass
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gastric Banding
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
M. Yanina Pepino
University of Illinois at Urbana Champaign
Phone: 217-300-2374
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place