NCT02497274

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 18, 2025

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

July 8, 2015

Last Update Submit

November 14, 2025

Conditions

Keywords

bariatric surgerytaste perceptionlipid receptors

Outcome Measures

Primary Outcomes (1)

  • 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

    before and 6 months after bariatric surgery

Secondary Outcomes (1)

  • Lipids thresholds

    before and 6 months after bariatric surgery

Other Outcomes (2)

  • Factors associated with taste perception

    before and 6 months after bariatric surgery

  • Influence of surgical technique on taste perception

    before and 6 months after bariatric surgery

Study Arms (2)

Roux Y gastric bypass

EXPERIMENTAL

candidates for bariatric surgery by Roux Y gastric bypass with taste assessment and epithelium gustatory smear and biopsy

Other: taste assessment and epithelium gustatory smear and biopsy

Sleeve gastrectomy

EXPERIMENTAL

candidates for bariatric surgery by sleeve gastrectomy with taste assessment and epithelium gustatory smear and biopsy

Other: taste assessment and epithelium gustatory smear and biopsy

Interventions

assessment of taste perceptions and expression of taste receptors before and after bariatric surgery and epithelium gustatory smear and biopsy

Roux Y gastric bypassSleeve gastrectomy

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bernard A, Le Beyec-Le Bihan J, Radoi L, Coupaye M, Sami O, Casanova N, Le May C, Collet X, Delaby P, Le Bourgot C, Besnard P, Ledoux S. Orosensory Perception of Fat/Sweet Stimuli and Appetite-Regulating Peptides before and after Sleeve Gastrectomy or Gastric Bypass in Adult Women with Obesity. Nutrients. 2021 Mar 8;13(3):878. doi: 10.3390/nu13030878.

  • Bernard A, Richard C, Radoi L, Boidot R, Ledoux S, Besnard P. Fat taste sensitivity in women with obesity: transcriptomic analysis of fungiform papillae before and after bariatric surgery. Obesity (Silver Spring). 2025 Aug;33(8):1518-1528. doi: 10.1002/oby.24325. Epub 2025 Jun 22.

  • Bernard A, Radoi L, Christensen J, Servant F, Blasco-Blaque V, Ledoux S, Collet X, Besnard P. A specific tongue microbiota signature is found in patients displaying an improvement of orosensory lipid perception after a sleeve gastrectomy. Front Nutr. 2023 Jan 11;9:1046454. doi: 10.3389/fnut.2022.1046454. eCollection 2022.

MeSH Terms

Conditions

Obesity

Interventions

Biopsy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Séverine Ledoux

    APHP-INSERM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 14, 2015

Study Start

January 11, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 18, 2025

Record last verified: 2021-08