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Completed

NCT Number: NCT01536197

Taste Perception Pre and Post Bariatric Surgery

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.

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Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric bypass

Procedure

Roux-en-Y gastric bypass

Gastric Banding

Procedure

Laparoscopic adjustable gastric banding

Sleeve gastrectomy

Procedure

Sleeve gastrectomy surgery

Primary outcomes

  1. 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).

Secondary outcomes

  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).

    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).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Effect of Bariatric Surgery-induced Weight Loss on Taste Perception

Acronym: RBtaste

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2012
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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