Obesity and Lipids: a Matter of Taste? (HumanFATaste)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
taste assessment and epithelium gustatory smear and biopsy
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring bariatric surgery, taste perception, lipid receptors
Eligibility Criteria
Inclusion Criteria:
- Affiliation to a health insurance
- Patients candidates for bariatric surgery based on criteria established by international experts (BMI> 40 or> 35 kg / m² with severe comorbidities, after failure of multidisciplinary care for a period of at least 1 year)
- Written consent after oral and written informations
Exclusion Criteria:
- Topic guardianship, curatorship or safeguard justice.
- Taking a treatment known to alter the perception of taste
- Oral Decay can affect the perception of taste
- Treatment that may interfere with intestinal peptides or lipids receptors (especially DDP4 inhibitors, anti-inflammatory medications, intestinal lipase inhibitors: Xenical)
- Tobacco use, alcohol or drugs abuse
- Known coagulopathy, abnormal hemostasis tests or abnormal platelets count, treatment interfering with coagulation or platelet aggregation
- Contraindication to bariatric surgery
- Malignant pathology, severe liver disease or severe inflammatory disease, malabsorption.
- Pregnancy
- Positive serology for VIH, VBH and CVH
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Roux Y gastric bypass
Sleeve gastrectomy
Arm Description
candidates for bariatric surgery by Roux Y gastric bypass with taste assessment and epithelium gustatory smear and biopsy
candidates for bariatric surgery by sleeve gastrectomy with taste assessment and epithelium gustatory smear and biopsy
Outcomes
Primary Outcome Measures
Expression of lipid receptors
To compare the expression of lipid receptors expressed in the taste buds before and after a significant weight loss induced by bariatric surgery
Secondary Outcome Measures
Lipids thresholds
To determine the relationship between taste receptor expression and changes in lipid and sugar perception thresholds before and after surgery
Full Information
NCT ID
NCT02497274
First Posted
July 8, 2015
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02497274
Brief Title
Obesity and Lipids: a Matter of Taste?
Acronym
HumanFATaste
Official Title
Obesity and Lipids: a Matter of Taste? Impact of Bariatric Surgery on Taste Receptors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the protocol is to determine the impact of bariatric surgery on taste receptors and taste perceptions and to precise the factors implicated in taste alterations in 50 obese patients before and 6 months after bariatric surgery (25 Roux Y gastric bypass and 25 sleeve gastrectomy).
Detailed Description
Over-consumption high sugar and high fat foods was identified as a main risk factor for obesity. The recent identification of lipid-receptor (CD36, GPR120) in human taste buds suggests that lipids could be perceived not only by their texture and their olfactory characteristics, but also by way of taste. Obese subjects tend to consume more high fat foods than lean subjects. Conversely, bariatric surgery induces behavioral changes limiting the consumption of foods high in sugar and fat. The mechanisms underlying these behavioral changes are not understood. Does obesity is accompanied by a distortion of taste detection of dietary lipids? What are the mechanisms involved? Are they reversible? What could be the effect on food choices and health? This protocol is part of a broader research program that aims to answer these questions by studying the feeding behavior in obese subjects and animals before and after a bariatric surgery.
The purpose of the protocol is to determine the impact of bariatric surgery on the expression of taste receptors and taste perceptions and in particular the threshold of perception of fat (and sweet as taste as reference) and to study the association between the changes of taste perceptions and food preferences, amount of weight loss, surgical technique (with or without intestinal bypass), hormonal, metabolic and inflammatory changes, and modification of the oral microbiota. The study will included 50 patients who underwent bariatric surgery, either Roux Y gastric bypass (25 patients) or sleeve gastrectomy (25 patients) that will be explored in the two months before and six months after surgery. These explorations will included a clinical examination with collection of anthropometric data, a body fat determination by impedance, a detailed dietary survey, blood samples for assessment of hormonal parameters (GLP1 , PYY, ghrelin, insulin, leptin) and inflammatory parameters (LPS, TNFalpha, IL-1, IL-6, ...), a tong micro-biopsy to collect taste buds and a sample of oral microbiota and lipids and sugars thresholds determination (linoleic acid or sucrose).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
bariatric surgery, taste perception, lipid receptors
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roux Y gastric bypass
Arm Type
Experimental
Arm Description
candidates for bariatric surgery by Roux Y gastric bypass with taste assessment and epithelium gustatory smear and biopsy
Arm Title
Sleeve gastrectomy
Arm Type
Experimental
Arm Description
candidates for bariatric surgery by sleeve gastrectomy with taste assessment and epithelium gustatory smear and biopsy
Intervention Type
Other
Intervention Name(s)
taste assessment and epithelium gustatory smear and biopsy
Intervention Description
assessment of taste perceptions and expression of taste receptors before and after bariatric surgery and epithelium gustatory smear and biopsy
Primary Outcome Measure Information:
Title
Expression of lipid receptors
Description
To compare the expression of lipid receptors expressed in the taste buds before and after a significant weight loss induced by bariatric surgery
Time Frame
before and 6 months after bariatric surgery
Secondary Outcome Measure Information:
Title
Lipids thresholds
Description
To determine the relationship between taste receptor expression and changes in lipid and sugar perception thresholds before and after surgery
Time Frame
before and 6 months after bariatric surgery
Other Pre-specified Outcome Measures:
Title
Factors associated with taste perception
Description
To identify the factors associated with the expression and functionality of taste receptors before and after bariatric surgery: body fat, metabolic, endocrine and inflammatory parameters and peripapillary microbiota.
Time Frame
before and 6 months after bariatric surgery
Title
Influence of surgical technique on taste perception
Description
To compare the effect of RYGBP which bypass the proximal gut with changes in intestinal endocrine secretions and lipid absorption, to that of SG that is a pure restrictive technique without intestinal bypass.
Time Frame
before and 6 months after bariatric surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Affiliation to a health insurance
Patients candidates for bariatric surgery based on criteria established by international experts (BMI> 40 or> 35 kg / m² with severe comorbidities, after failure of multidisciplinary care for a period of at least 1 year)
Written consent after oral and written informations
Exclusion Criteria:
Topic guardianship, curatorship or safeguard justice.
Taking a treatment known to alter the perception of taste
Oral Decay can affect the perception of taste
Treatment that may interfere with intestinal peptides or lipids receptors (especially DDP4 inhibitors, anti-inflammatory medications, intestinal lipase inhibitors: Xenical)
Tobacco use, alcohol or drugs abuse
Known coagulopathy, abnormal hemostasis tests or abnormal platelets count, treatment interfering with coagulation or platelet aggregation
Contraindication to bariatric surgery
Malignant pathology, severe liver disease or severe inflammatory disease, malabsorption.
Pregnancy
Positive serology for VIH, VBH and CVH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Séverine Ledoux
Organizational Affiliation
APHP-INSERM
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Obesity and Lipids: a Matter of Taste?
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