Food Preferences Variations Depending on Bariatric Surgery StatusNCT03486210
Pilot Suty of the Assessment of Food Preferences After Bariatric Surgery (BariaTaste Pilot)
An observational study of Food Preferences Variations Depending on Bariatric Surgery Status, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
More than 50,000 patients in France benefit from bariatric surgery every year. However, nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or secondary weight failures (weight recovery) account for almost 20% of operated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Preferences Variations Depending on Bariatric Surgery Status
- What is being tested?
- Food preference and Psychological assesment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2018to 10 Jul 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will focus on a population of patients who are or have been obese and are being cared for at the Lyon Sud Hospital Center. Patients will either be undergoing initial assessment or being assessed for follow-up after bariatric surgery (after sleeve gastrectomy or gastric bypass).
Who may be able to join
- Patient, male or female, between 18 to 65 years old
- Patient with a BMI between 18.5 and 60 kg / m2: minimum 35 kg / m2 for the obesity group
- Patient undergoing initial assessment before bariatric surgery for the obesity group
- Patient being assessed for follow-up after bariatric surgery (after sleeve gastrectomy or gastric bypass)
- Patient agreeing to participate in the study.
- Patient affiliated to a Social Security scheme or beneficiary of such a scheme
Who cannot join
- Patient with other psychiatric comorbidities, including a bipolar mood disorder or eating disorder
- Patient with food eviction, whether medical or cultural
- Patient with ongoing psychotropic treatment (except anxiolytic treatment)
- Patient unable to give his agreement, not mastering the French language,
- Patient under authorship or curators
Trial locations and contacts
1 site in 1 country.
About this study
More than 50,000 patients in France benefit from bariatric surgery every year. However, nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or secondary weight failures (weight recovery) account for almost 20% of operated. Weight loss and the metabolic effects of surgery are not related only to a reduction in dietary intakes, but also to mechanisms independent of caloric reduction, such as eating behaviour after bariatric surgery (Gastric Bypass or sleeve gastrectomy). These choices are guided by perceived changes in the properties of the food, resulting in changes in tastes, palatability and more generally food preferences. Among available tools to evaluate dietary preferences we selected the Food Leeds Preference Questionnaire (FLPQ) to assess those modifications. During this test, photographs of food products classified according to predetermined characteristics are presented with different instructions and response design to estimate liking, wanted for food, implicitly or explicitly. Our main hypothesis is that the use of the Food Leeds Preference Questionnaire will highlight differences in dietary preferences according to the type of bariatric surgery performed.
We will be conducted a study observational study on three parallel groups: a control group composed of patients suffering from unoperated obesity, a group of patients operated for a sleeve gastrectomy and a group of patients operated for a gastric bypass. We will include 45 patients per group. The patients will have to pass the Leeds Food Preference Questionnaire (LFPQ). Our judgment criterion will be the degree of food preference assessed using the LFPQ. Participants will also be assessed on behavioural parameters with the Binge Eating Scale, the Yale Food Addiction Scale Version 2.0 and the Urgency, lack of Premeditation, lack of Perseverance and Sensation seeking Impulsive behavior scale (UPPS-P) short version.
- Being tested
- Food preference, Psychological assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food preferenceBehavioural
The study will take place in two phases. A first phase will consist in the validation of translations and the selection of images on 20 healthy volunteers and 20 health professionals specialized in nutrition. They will have to fill a form with images of food and evaluate to what extend they think the pictures represent what we can eat in France. This step will adapt the questionnaire to our country.
Psychological assesmentOther
Phase performed with patients fasting for at least 2 hours before the different tests. The FLPQ will be compared between a group of patients suffering from unoperated obesity (OCt), a group of patients operated on a sleeve gastrectomy (OSl) and a group operated by a bypass (OBy) between 6 and 24 months post-surgery, randomized for the 6 combined tests (2 categories). The award can be made in 2 sessions of at least 3 of the 6 tests combined. Each test combines 2 of the 11 categories. The test will consist of 96 pairs of 16 food images presented on a computer screen in color. Participants will be invited to "choose the food they most want to eat", by pressing the corresponding computer button (choices saved by counting the frequency scores in E-prime).
The level of hunger will be evaluated by an Analogical Visual Scale, ranging from 0 to 10.
Patients should also complete 3 self-questionnaires used routinely (Binge Eating Scale, The Yale Food Addiction Scale, The UPPS-P short version).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Group 1 | Healthy volunteers Receives: Behavioral: Food preference | |
| Phase 1 Group 2 | Health professionals Receives: Behavioral: Food preference | |
| Phase 2 Group 1 | Control group : patients obese without surgery Receives: Other: Psychological assesment | |
| Phase 2 Group 2 | Patients who have underwent a sleeve gastrectomy Receives: Other: Psychological assesment | |
| Phase 2 Group 3 | Patients who have underwent a gastric bypass Receives: Other: Psychological assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of food preference
The degree of food preference will be measured using the Leeds Food Preference Questionnaire, that the investigator will have previously adapted in French for French population, in the form of counting frequency scores for each category of images.
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 posted3 Apr 2018
- Study start4 Jun 2018
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Preferences Variations Depending on Bariatric Surgery StatusStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain ICETA, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486210
- Sponsor's protocol ID
- 69HCL17_0694
- Status last verified
- Jun 2021
- First submitted
- 27 Mar 2018
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Suty of the Assessment of Food Preferences After Bariatric Surgery (BariaTaste Pilot)
- ClinicalTrials.gov ID
- NCT03486210
- Acronym / sponsor ID
- 69HCL17_0694
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 3 Apr 2018 (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.
More than 50,000 patients in France benefit from bariatric surgery every year. However, nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or secondary weight failures (weight recovery) account for almost 20% of operated. Weight loss and the metabolic effects of surgery are not related only to a reduction in dietary intakes, but also to mechanisms independent of caloric reduction, such as eating behaviour after bariatric surgery (Gastric Bypass or sleeve gastrectomy). These choices are guided by perceived changes in the properties of the food, resulting in changes in tastes, palatability and more generally food preferences. Among available tools to evaluate dietary preferences we selected the Food Leeds Preference Questionnaire (FLPQ) to assess those modifications. During this test, photographs of food products classified according to predetermined characteristics are presented with different instructions and response design to estimate liking, wanted for food, implicitly or explicitly. Our main hypothesis is that the use of the Food Leeds Preference Questionnaire will highlight differences in dietary preferences according to the type of bariatric surgery performed.
We will be conducted a study observational study on three parallel groups: a control group composed of patients suffering from unoperated obesity, a group of patients operated for a sleeve gastrectomy and a group of patients operated for a gastric bypass. We will include 45 patients per group. The patients will have to pass the Leeds Food Preference Questionnaire (LFPQ). Our judgment criterion will be the degree of food preference assessed using the LFPQ. Participants will also be assessed on behavioural parameters with the Binge Eating Scale, the Yale Food Addiction Scale Version 2.0 and the Urgency, lack of Premeditation, lack of Perseverance and Sensation seeking Impulsive behavior scale (UPPS-P) short version.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Group 1 | – | Behavioral: Food preferenceHealthy volunteers |
| Phase 1 Group 2 | – | Behavioral: Food preferenceHealth professionals |
| Phase 2 Group 1 | – | Other: Psychological assesmentControl group : patients obese without surgery |
| Phase 2 Group 2 | – | Other: Psychological assesmentPatients who have underwent a sleeve gastrectomy |
| Phase 2 Group 3 | – | Other: Psychological assesmentPatients who have underwent a gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will focus on a population of patients who are or have been obese and are being cared for at the Lyon Sud Hospital Center. Patients will either be undergoing initial assessment or being assessed for follow-up after bariatric surgery (after sleeve gastrectomy or gastric bypass).
Key inclusion criteria (6 listed)
- Patient, male or female, between 18 to 65 years old
- Patient with a BMI between 18.5 and 60 kg / m2: minimum 35 kg / m2 for the obesity group
- Patient undergoing initial assessment before bariatric surgery for the obesity group
- Patient being assessed for follow-up after bariatric surgery (after sleeve gastrectomy or gastric bypass)
- Patient agreeing to participate in the study.
Key exclusion criteria (5 listed)
- Patient with other psychiatric comorbidities, including a bipolar mood disorder or eating disorder
- Patient with food eviction, whether medical or cultural
- Patient with ongoing psychotropic treatment (except anxiolytic treatment)
- Patient unable to give his agreement, not mastering the French language,
- Patient under authorship or curators
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 |
|---|---|---|
| Food preferenceThe study will take place in two phases. A first phase will consist in the validation of translations and the selection of images on 20 healthy volunteers and 20 health professionals specialized in nutrition. They will have to fill a form with images of food and evaluate to what extend they think the pictures represent what we can eat in France. This step will adapt the questionnaire to our country. | Behavioural | Phase 1 Group 1, Phase 1 Group 2 |
| Psychological assesmentPhase performed with patients fasting for at least 2 hours before the different tests. The FLPQ will be compared between a group of patients suffering from unoperated obesity (OCt), a group of patients operated on a sleeve gastrectomy (OSl) and a group operated by a bypass (OBy) between 6 and 24 months post-surgery, randomized for the 6 combined tests (2 categories). The award can be made in 2 sessions of at least 3 of the 6 tests combined. Each test combines 2 of the 11 categories. The test will consist of 96 pairs of 16 food images presented on a computer screen in color. Participants will be invited to "choose the food they most want to eat", by pressing the corresponding computer button (choices saved by counting the frequency scores in E-prime). The level of hunger will be evaluated by an Analogical Visual Scale, ranging from 0 to 10. Patients should also complete 3 self-questionnaires used routinely (Binge Eating Scale, The Yale Food Addiction Scale, The UPPS-P short version). | Other | Phase 2 Group 1, Phase 2 Group 2, Phase 2 Group 3 |
Primary outcome
Degree of food preference
Time frame: Day 1
The degree of food preference will be measured using the Leeds Food Preference Questionnaire, that the investigator will have previously adapted in French for French population, in the form of counting frequency scores for each category of images.
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 18 Jun 2021.
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.
Sylvain ICETA, MD principal investigator
Hospices Civils de Lyon
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 Food Preferences Variations Depending on Bariatric Surgery Status, 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 5 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 18 Jun 2021. 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?
Degree of food preference (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 18 Jun 2021.