- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511442
Study of Food Preferences and Sensory Perceptions After Bariatric Surgery (BariaTaste 2)
Comparative Study of Differences in Food Preferences and Sensory Perceptions Between People With Obesity With or Without Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Julie-Anne Nazare
- Phone Number: +33 4 78 86 29 81
- Email: julie-anne.nazare@univ-lyon1.fr
Study Contact Backup
- Name: Erika Guyot
- Phone Number: +33 6 09 96 70 59
- Email: ext-erika.guyot@chu-lyon.fr
Study Locations
-
-
-
Lyon, France
- : Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Bariatric surgery
Women with obesity, with a bariatric surgery
|
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:
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
|
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:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0182
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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