NCT04511442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

July 16, 2020

Last Update Submit

March 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Bariatric surgery

Women with obesity, with a bariatric surgery

Other: Evaluation of food preferences during a standardized and validated buffet.

Control

Women with obesity, without a bariatric surgery

Other: Evaluation of food preferences during a standardized and validated buffet.

Interventions

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.

Bariatric surgeryControl

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

: Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center

Lyon, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

August 13, 2020

Study Start

April 26, 2021

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations