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Taste Perception Pre and Post Bariatric Surgery (RBtaste)

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ClinicalTrials.gov Identifier: NCT01536197
Recruitment Status : Completed
First Posted : February 20, 2012
Results First Posted : July 3, 2014
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Morbid Obesity
Interventions Procedure: Gastric bypass
Procedure: Gastric banding
Procedure: Sleeve gastrectomy
Enrollment 33

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gastric Bypass Gastric Banding
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morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding

Period Title: Overall Study
Started 23 10
Completed 23 10
Not Completed 0 0
Arm/Group Title Gastric Bypass Gastric Banding Total
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morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding

Total of all reporting groups
Overall Number of Baseline Participants 23 10 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 10 participants 33 participants
43.0  (9.6) 46.8  (13.9) 43.5  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 10 participants 33 participants
Female
20
  87.0%
10
 100.0%
30
  90.9%
Male
3
  13.0%
0
   0.0%
3
   9.1%
Body weight before surgery  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 23 participants 10 participants 33 participants
129.8  (26.1) 127.1  (31.0) 128.7  (27.2)
1.Primary Outcome
Title Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).
Hide Description -Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gastric Bypass Gastric Banding
Hide Arm/Group Description:

morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding

Overall Number of Participants Analyzed 23 10
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
Sucrose taste detection threshold before surgery
7.5
(2.4 to 12.6)
8.1
(6.5 to 11.5)
Sucrose taste detection threshold after surgery
6.5
(4.6 to 8.4)
7.5
(4.9 to 13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gastric Bypass, Gastric Banding
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method ANOVA
Comments Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).
2.Secondary Outcome
Title 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).
Hide Description -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).
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gastric Bypass Gastric Banding
Hide Arm/Group Description:

morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding

Overall Number of Participants Analyzed 23 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Cravings for sweets before surgery 2.3  (0.8) 2.7  (0.7)
Cravings for sweets after surgery 1.6  (0.6) 2.3  (0.5)
Cravings for fast food before surgery 2.9  (0.7) 2.6  (0.8)
Cravings for fast food after surgery 2.2  (0.6) 2.2  (0.5)
Cravings for high fat food before surgery 2.2  (0.7) 2.0  (0.8)
Cravings for high fat food after surgery 1.8  (0.6) 1.9  (0.7)
Cravings for starchy food before surgery 2.2  (0.8) 2.2  (0.5)
Cravings for starchy food after surgery 1.9  (0.7) 1.9  (0.6)
Restrained eating before surgery 2.9  (0.6) 2.8  (0.5)
Restrained eating after surgery 3.0  (0.7) 3.4  (1)
Emotional eating before surgery 2.6  (0.9) 3.2  (1.0)
Emotional eating after surgery 1.8  (0.7) 2.3  (1.0)
External eating before surgery 3.0  (0.5) 3.4  (0.5)
External eating after surgery 2.2  (0.5) 2.4  (0.6)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gastric Bypass Gastric Banding
Hide Arm/Group Description

morbidly obese subjects undergoing gastric bypass surgery

Gastric bypass: Roux-en-Y gastric bypass

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Gastric banding: Laparoscopic adjustable gastric banding

All-Cause Mortality
Gastric Bypass Gastric Banding
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gastric Bypass Gastric Banding
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gastric Bypass Gastric Banding
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: M. Yanina Pepino
Organization: University of Illinois at Urbana Champaign
Phone: 217-300-2374
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01536197     History of Changes
Other Study ID Numbers: 09-0175B
First Submitted: February 9, 2012
First Posted: February 20, 2012
Results First Submitted: June 2, 2014
Results First Posted: July 3, 2014
Last Update Posted: December 18, 2017