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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
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring bariatric surgery, taste perception, lipid receptors

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 8, 2015
    Last Updated
    August 25, 2021
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
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    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

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    Obesity and Lipids: a Matter of Taste?

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