Taste Perception Pre and Post Bariatric Surgery (RBtaste)

November 6, 2017 updated by: Washington University School of Medicine

Effect of Bariatric Surgery-induced Weight Loss on Taste Perception

The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 41 morbidly obese (BMI>=35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.

Description

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 intestinal 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Sleeve gastrectomy
morbidly obese subjects undergoing sleeve gastrectomy surgery
Procedure: Sleeve gastrectomy
Sleeve gastrectomy surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on Taste Detection Thresholds 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
-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
-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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Samuel Klein, M.D., Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimate)

February 20, 2012

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0175B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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