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Study of Food Preferences and Sensory Perceptions After Bariatric Surgery (BariaTaste 2)

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ClinicalTrials.gov Identifier: NCT04511442
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
Several studies report changes in food preferences in favor of low energy density foods after bariatric surgery and changes in scores of liking and desire to eat, as well as changes in hedonic evaluation certain foods. However, only one study was held in a more realistic condition of consumption by using real food, looking at some aspects of food preferences and giving contradictory results. We hypothesise that food preferences are different between obese people with and without a bariatric surgery. The main objective of this study is to compare the differences in food quality (proportion of total energy intake from foods with high energy density versus foods with low energy density), evaluated during a standardized and validated buffet between adult women with severe complicated or morbid obesity and women who have undergone bariatric surgery in the last 12 months.

Condition or disease Intervention/treatment
Obesity Other: Evaluation of food preferences during a standardized and validated buffet.

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparative Study of Differences in Food Preferences and Sensory Perceptions Between People With Obesity With or Without Bariatric Surgery
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Bariatric surgery
Women with obesity, with a bariatric surgery
 Other: Evaluation of food preferences during a standardized and validated buffet.

The dietary preferences of people will be collected by a direct measurement of eating behavior in front of a dedicated and standardized ad-libitum buffet.

As part of this buffet, 3 dichotomous categories of food will be studied:

  • high / low in fat (HF / LF)
  • high / low in carbohydrates (HC / LC)
  • high / low in protein (HP / LP). During the buffet, participants will be filmed to study their food choices and the microstructure of their meal. We will define food preferences as the relative consumption choices of the food categories studied. We will also collect the time spent at the buffet, the duration of ingestion, the total duration of the meal, the number of bites per minute, the total number of bites and the number of bites by type of food.

Weighing's will be carried out before and after consumption in order to determine the total energy intake and the macronutrient intake (proteins, lipids, carbohydrates) of the participants.
Control
Women with obesity, without a bariatric surgery
 Other: Evaluation of food preferences during a standardized and validated buffet.

The dietary preferences of people will be collected by a direct measurement of eating behavior in front of a dedicated and standardized ad-libitum buffet.

As part of this buffet, 3 dichotomous categories of food will be studied:

  • high / low in fat (HF / LF)
  • high / low in carbohydrates (HC / LC)
  • high / low in protein (HP / LP). During the buffet, participants will be filmed to study their food choices and the microstructure of their meal. We will define food preferences as the relative consumption choices of the food categories studied. We will also collect the time spent at the buffet, the duration of ingestion, the total duration of the meal, the number of bites per minute, the total number of bites and the number of bites by type of food.

Weighing's will be carried out before and after consumption in order to determine the total energy intake and the macronutrient intake (proteins, lipids, carbohydrates) of the participants.


Outcome Measures
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Primary Outcome Measures :
  1. Food preference for high energy dense foods [ Time Frame: Day 1 ]
    The main endpoint of the study is the proportion of total energy intake from foods with high energy density versus foods with low energy density evaluated during a standardized and validated buffet.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
This study will focus on adult female volunteers with severe complicated or morbid obesity who may or may not have undergone bariatric surgery in the past 12 months.
Criteria

Inclusion Criteria:

  • Woman from 18 to 65 years old (included)
  • Person capable of going to the Institut Paul Bocuse Research Center, Bellecour platform, 20 Place Bellecour, 69002 Lyon
  • Person who agree to participate in the study
  • Person having signed the consent of image rights
  • For the surgery group: person who has undergone bariatric surgery (except gastric band)
  • For the control group: person with a BMI ≥ 35 kg / m2 who did not benefit from bariatric surgery

Exclusion Criteria:

  • Person with a food allergy or food intolerance to at least one of the study products
  • Person excluding certain foods from their diet for religious or personal reasons.
  • Person who smoke
  • Person with severe digestive disorders, dysphagia, abdominal pain
  • Person who cannot give her agreement, not mastering the French language
  • Person who has exceeded the annual amount of compensation in the year for participation in research protocols
  • Pregnant or breastfeeding woman or not taking effective contraception
  • Person with a history of pathology which may interfere according to the investigator with the criteria of the study (ENT, neurological, upper digestive pathologies, ...)
  • For the surgery group: conversion of any type of bariatric surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511442


Contacts
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Contact: Julie-Anne Nazare 4 78 86 29 81 ext +33 julie-anne.nazare@univ-lyon1.fr
Contact: Erika Guyot 6 09 96 70 59 ext +33 ext-erika.guyot@chu-lyon.fr

Locations
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France
: Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center Recruiting
Lyon, France
Contact: Julie-Anne Nazare    4 78 86 29 81 ext +33    julie-anne.nazare@univ-lyon1.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04511442    
Other Study ID Numbers: 69HCL20_0182
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight