ObesityBariaTaste 2NCT04511442
Study of Food Preferences and Sensory Perceptions After Bariatric Surgery
An observational study of Obesity, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Evaluation of food preferences during a standardized and validated buffet.
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2021to 21 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
: Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center
Lyon
About this study
Official title: Comparative Study of Differences in Food Preferences and Sensory Perceptions Between People With Obesity With or Without Bariatric Surgery
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.
- Conditions
- Obesity
- Being tested
- Evaluation of food preferences during a standardized and validated buffet.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of food preferences during a standardized and validated buffet.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Women with obesity, with a bariatric surgery Receives: Other: Evaluation of food preferences during a standardized and validated buffet. | |
| Control | Women with obesity, without a bariatric surgery Receives: Other: Evaluation of food preferences during a standardized and validated buffet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start26 Apr 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511442
- Sponsor's protocol ID
- 69HCL20_0182
- Acronym
- BariaTaste 2
- Status last verified
- Mar 2023
- First submitted
- 16 Jul 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Differences in Food Preferences and Sensory Perceptions Between People With Obesity With or Without Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04511442
- Acronym / sponsor ID
- BariaTaste 2 / 69HCL20_0182
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | Other: Evaluation of food preferences during a standardized and validated buffet.Women with obesity, with a bariatric surgery |
| Control | – | Other: Evaluation of food preferences during a standardized and validated buffet.Women with obesity, without a bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Bariatric surgery, Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food preference for high energy dense foods (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.