Bariatric Surgery CandidateBariaTaste3NCT03911115
Food Preferences After Bariatric Surgery (BariaTaste 3)
An observational study of Bariatric Surgery Candidate, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Bariatric surgery is currently considered the most effective treatment for achieving significant, sustained weight loss and reducing comorbidities associated with obesity. Every year in France, more than 55,000 undergo this surgery and nearly 450 000 French have a history of surgery for obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Food preference questionnaire
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2019to 4 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone a bariatric surgery, Roux-en-Y Gastric Bypass (RYGB) or sleeve gastrectomy (SG)
Who may be able to join
- Patient who have undergone a Roux-en-Y Gastric Bypass (RYGB) or a sleeve gastrectomy (SG)
- Patient aged at least 18
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Food Preferences After Bariatric Surgery
Bariatric surgery is currently considered the most effective treatment for achieving significant, sustained weight loss and reducing comorbidities associated with obesity. Every year in France, more than 55,000 undergo this surgery and nearly 450 000 French have a history of surgery for obesity. The mechanisms of action of bariatric surgery are multiple and are not limited to caloric restriction. Neuro-hormonal effects, changes in the anatomy of the digestive tract, vagal changes or bile circulation have been identified as contributing factors to weight loss and postoperative improvement of comorbidities. In addition, post-operative changes in dietary preferences have also been described, which could contribute to initial weight loss and its maintenance over time (aversion to lipid and sugar products).
The counterpart of the rapid and durable efficacy of bariatric surgery is the exposure of patients to a significant risk of protein-energy malnutrition. It should be noted that the protein intake, very limited in the first months after surgery, remains well below the recommended intake after the first postoperative year. Spontaneous consumption of meat and vegetable protein is significantly reduced during the first postoperative month and up to one year after surgery. Apart from the limitation of gastric volume induced by surgery, clinical experience indicates that many patients turn away from protein consumption by aversion. A parallel was made between the significant drop in protein consumption during the first months and the initial loss of lean mass. Thus changes in dietary preferences induced by bariatric surgery could also contribute to postoperative nutritional risk (protein aversion).
Read more
At the same time, it is noted that olfactory and taste modifications have been reported in previous studies that could be associated with these changes in food preferences.
The hypotheses of the current study are that the type of surgery may affect dietary preferences differently after obesity surgery and that surgical failure may be associated with preferences for high fat, high sweet and low protein foods postoperatively for both types of surgery.
As far as the investigating team is aware, no study compares dietary preferences between sleeve gastrectomy and gastric bypass using this approach.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Food preference questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food preference questionnaireOther
This is an online questionnaire administrated once to the participants, to assess food preferences after bariatric surgery. The investigating team will also collect data on the type of surgery, anthropometry, nutrition, taste, smell, disgust and intolerance as well as sociodemographic data.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Individuals that have undergone a gastric bypass (RYGB) or a sleeve gastrectomy (SG) Receives: Other: Food preference questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food preferences
Food preferences will be measured using liking score for different food groups.The outcome will be assessed in the period following the bariatric surgery.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start24 May 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erika Guyot, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911115
- Sponsor's protocol ID
- 69HCL19_0219
- Other IDs
- 2019-A00774-53
- Acronym
- BariaTaste3
- Status last verified
- Dec 2019
- First submitted
- 5 Apr 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Food Preferences After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03911115
- Acronym / sponsor ID
- BariaTaste3 / 69HCL19_0219
- Conditions
- Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 10 Apr 2019 (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.
Bariatric surgery is currently considered the most effective treatment for achieving significant, sustained weight loss and reducing comorbidities associated with obesity. Every year in France, more than 55,000 undergo this surgery and nearly 450 000 French have a history of surgery for obesity. The mechanisms of action of bariatric surgery are multiple and are not limited to caloric restriction. Neuro-hormonal effects, changes in the anatomy of the digestive tract, vagal changes or bile circulation have been identified as contributing factors to weight loss and postoperative improvement of comorbidities. In addition, post-operative changes in dietary preferences have also been described, which could contribute to initial weight loss and its maintenance over time (aversion to lipid and sugar products).
The counterpart of the rapid and durable efficacy of bariatric surgery is the exposure of patients to a significant risk of protein-energy malnutrition. It should be noted that the protein intake, very limited in the first months after surgery, remains well below the recommended intake after the first postoperative year. Spontaneous consumption of meat and vegetable protein is significantly reduced during the first postoperative month and up to one year after surgery. Apart from the limitation of gastric volume induced by surgery, clinical experience indicates that many patients turn away from protein consumption by aversion. A parallel was made between the significant drop in protein consumption during the first months and the initial loss of lean mass. Thus changes in dietary preferences induced by bariatric surgery could also contribute to postoperative nutritional risk (protein aversion).
At the same time, it is noted that olfactory and taste modifications have been reported in previous studies that could be associated with these changes in food preferences.
The hypotheses of the current study are that the type of surgery may affect dietary preferences differently after obesity surgery and that surgical failure may be associated with preferences for high fat, high sweet and low protein foods postoperatively for both types of surgery.
As far as the investigating team is aware, no study compares dietary preferences between sleeve gastrectomy and gastric bypass using this approach.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | Other: Food preference questionnaireIndividuals that have undergone a gastric bypass (RYGB) or a sleeve gastrectomy (SG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone a bariatric surgery, Roux-en-Y Gastric Bypass (RYGB) or sleeve gastrectomy (SG)
Key inclusion criteria (2 listed)
- Patient who have undergone a Roux-en-Y Gastric Bypass (RYGB) or a sleeve gastrectomy (SG)
- Patient aged at least 18
Key exclusion criteria (1 listed)
- None
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 preference questionnaireThis is an online questionnaire administrated once to the participants, to assess food preferences after bariatric surgery. The investigating team will also collect data on the type of surgery, anthropometry, nutrition, taste, smell, disgust and intolerance as well as sociodemographic data. | Other | Bariatric surgery |
Primary outcome
Food preferences
Time frame: Day 0
Food preferences will be measured using liking score for different food groups.The outcome will be assessed in the period following the bariatric surgery.
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 6 Dec 2019.
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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.
Erika Guyot, Dr 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 Bariatric Surgery Candidate, 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 2 inclusion and 1 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 6 Dec 2019. 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 preferences (time frame: Day 0). 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 6 Dec 2019.