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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04511442
Other study ID # 69HCL20_0182
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 26, 2021
Est. completion date December 21, 2021

Study information

Verified date March 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France : Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Food preference for high energy dense foods 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
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