Taste Perception Pre and Post Bariatric Surgery (RBtaste)
This study is ongoing, but not recruiting participants.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01536197
First received: February 9, 2012
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
The investigators wish to study the effects of two forms of bariatric surgery, gastric bypass and lap banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight-loss on taste perception.
| Condition | Intervention |
|---|---|
|
Morbid Obesity |
Procedure: Gastric bypass Procedure: Gastric banding |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Bariatric Surgery-induced Weight Loss on Taste Perception |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- Changes on taste detection thresholds, taste strength above detection thresholds and taste favorite concentration after bariatric surgery-induced weight loss (Roux-en-Y gastric bypass and laparoscopic adjustable banding). [ 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 ] [ Designated as safety issue: No ]
- Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
- Perception of taste intensity above thresholds measures perceive changes in intensity taste as the concentration of the stimulus (e.g. sucrose, sodium chloride) increases. This measures correlates with subject's real taste-world sensations.
- Taste preferences measures the favorite level of tastant in a solution (e.g. favorite level of sugar in a liquid).
Secondary Outcome Measures:
- 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). [ 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 ] [ Designated as safety issue: No ]-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire and the Food Craving Inventory.
Other Outcome Measures:
- Effects of surgery-induced weight loss on cellular factors involved in the transduction of taste signals in fungiform papillae (Roux-en-Y gastric bypass and laparoscopic adjustable banding). [ 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 ] [ Designated as safety issue: No ]We will measure expression of taste-related genes in biopsies of lingual fungiform papillae by real-time polymerase chain reaction.
Biospecimen Retention: Samples With DNA
Tongue tissue
| Estimated Enrollment: | 27 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Gastric Bypass
morbidly obese subjects undergoing gastric bypass surgery
|
Procedure: Gastric bypass
Roux-en-Y gastric bypass
|
|
Gastric banding
morbidly obese subjects undergoing laparoscopic gastric banding surgery
|
Procedure: Gastric banding
Laparoscopic adjustable gastric banding
|
Detailed Description:
Bariatric surgery is the most effective weight loss therapy for obesity. However, the mechanisms responsible for decreased food intake are incompletely understood. One possible mechanism that could account for decreased food intake is changes in taste perception. Therefore, the primary goal of this proposal is to provide a better understanding of the effects of bariatric surgery-induced weight-loss on taste perception.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
A total of 27 morbidly obese (BMI>=35 kg/m2)subjects schedule for bariatric surgical procedures will participate in this study.
Criteria
Inclusion Criteria:
- BMI >=35 kg/m2
- on stable dose of medication for at least 4 weeks before the pre-surgery studies
- women
Exclusion Criteria:
- smokes > 7 cigarettes per day
- previous malabsorptive or restrictive intestinal surgery
- pregnant or breastfeeding
- recent history of neoplasia (< 5 years ago)
- have malabsorptive syndromes and inflammatory intestina disease
- diabetes mellitus
- show signs of oral disease or xerostomia (i.e. dry mouth)
- history of chronic rhinitis
- on medication that might affect taste
- severe organ disfunction
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536197
Locations
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Samuel Klein, M.D. | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01536197 History of Changes |
| Other Study ID Numbers: | 09-0175B |
| Study First Received: | February 9, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
obesity gastric bypass gastric banding weight loss taste perception |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013