OTB: The Obese Taste Bud Study

Sponsor
University of Leipzig (Other)
Overall Status
Recruiting
CT.gov ID
NCT04633109
Collaborator
Helmholtz Institut für Metabolismus-, Adipositas- und Gefäßforschung (Other), Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde (Other), Klinik und Poliklinik für Mund-, Kiefer- und Plastische Gesichtschirurgie (Other), Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde (Other)
210
1
20.6
10.2

Study Details

Study Description

Brief Summary

The sense of taste is essential for priming food preferences and is therefore important for caloric uptake and body weight regulation. Recent studies show that obesity is linked to changes in taste sensation but also to a loss of taste buds on the tongue. This study aims to evaluate underlying mechanisms within the taste buds to potentially influence the sense of taste on the level of these sensory cells and in order to develop new treatment strategies to fight obesity.

Condition or Disease Intervention/Treatment Phase
  • Procedure: taste bud biopsy
  • Diagnostic Test: oral glucose tolerance test
  • Diagnostic Test: Taste sensitivity
  • Diagnostic Test: olfactory function
  • Diagnostic Test: taste bud density
  • Diagnostic Test: anthropometry
  • Other: biospecimen collection
  • Other: questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
210 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Obese Taste Bud Study
Actual Study Start Date :
Nov 9, 2020
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
normal weight

Normal weight adults with BMI ranging from 18.5-24.9; men and women; age range 18-69years; written informed consent

Procedure: taste bud biopsy
Taste buds will be surgically removed a) during a planned and medically induced elective surgery under full anesthesia; b) by local anesthesia in subjects without a medically induced surgery

Diagnostic Test: oral glucose tolerance test
75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.

Diagnostic Test: Taste sensitivity
Subjects are given taste strips with 4 concentrations per each taste quality of sweet, sour, salty, bitter and umami in a pseudo-randomized manner. Subjects are asked to identify the taste quality, state the intensity, preference and certainty.

Diagnostic Test: olfactory function
Subjects will be presented 16 different sniffing sticks in a randomized order, each for about 4seconds. People are then asked to identify the smell by choosing one out of 4 options (forced choice).

Diagnostic Test: taste bud density
The number of taste buds on the anterior tongue will be determined by colouring the tongue surface with food colour. Taste buds will apply more reddish as compared to non-taste tissue. Based on a digital photography the number of taste buds per subjects is counted manually.

Diagnostic Test: anthropometry
Anthropometric data collection will include measures of body height, body weight, arm-, upper- and lower leg circumferences, waist- and hip circumferences and a bioimpedance analysis to obtain data about body composition.

Other: biospecimen collection
Blood and saliva samples will be taken as well as a tongue swab.

Other: questionnaires
Through the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained.

obese

Subjects with obesity as defined by BMI >= 30; men and women; age range 18-69 years; written informed consent

Procedure: taste bud biopsy
Taste buds will be surgically removed a) during a planned and medically induced elective surgery under full anesthesia; b) by local anesthesia in subjects without a medically induced surgery

Diagnostic Test: oral glucose tolerance test
75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.

Diagnostic Test: Taste sensitivity
Subjects are given taste strips with 4 concentrations per each taste quality of sweet, sour, salty, bitter and umami in a pseudo-randomized manner. Subjects are asked to identify the taste quality, state the intensity, preference and certainty.

Diagnostic Test: olfactory function
Subjects will be presented 16 different sniffing sticks in a randomized order, each for about 4seconds. People are then asked to identify the smell by choosing one out of 4 options (forced choice).

Diagnostic Test: taste bud density
The number of taste buds on the anterior tongue will be determined by colouring the tongue surface with food colour. Taste buds will apply more reddish as compared to non-taste tissue. Based on a digital photography the number of taste buds per subjects is counted manually.

Diagnostic Test: anthropometry
Anthropometric data collection will include measures of body height, body weight, arm-, upper- and lower leg circumferences, waist- and hip circumferences and a bioimpedance analysis to obtain data about body composition.

Other: biospecimen collection
Blood and saliva samples will be taken as well as a tongue swab.

Other: questionnaires
Through the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained.

Outcome Measures

Primary Outcome Measures

  1. Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects [through study completion, an average of 2 years]

    Transcriptomics (RNAsequencing (seq), single cell seq) and epigenomics (open chromatin mapping (ATACseq), Infinium MethylationEPIC Array) will be performed in isolated papillae fungiformes. Validation analyses by in vitro primary cell cultures of taste cell biopsy

  2. Identification of correlations between taste cell biology with parameters of intervention [1 year]

    corrleation analyses will include factors of eating behavior, food preferences, life style factors, data from taste and smell screenings, anthropometric data, blood and saliva parameters

Secondary Outcome Measures

  1. Differences of salivary and tongue microbiome on taste cells in obesity in contrast to lean [2 years]

    whole mouth saliva as well as local tongue microbiome diversity will be analysed by 16S ribosomal RNA seq and related to further parameters of this study.

  2. extracellular vesicle analyses of saliva in lean and obese subjects [2 years]

    The content of extracellular vesicles from saliva samples will be analysed and compared between the study groups as well as related to other parameters of this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • normal weight (BMI 18.5-24.9)

  • obesity (BMI >=30)

  • overall healthy (no severe sickness, no cancer)

  • written informed consent

Exclusion Criteria:
  • current pregnancy or currently breastfeeding

  • cancer or tumors

  • state after radiotherapy at head-neck area

  • state after or current chemotherapy

  • severe psychiatric-, cardiac-, kidney- or neurological illness

  • diagnosed diabetes mellitus

  • known dysfunction of smelling or tasting

  • drug or alcohol abuse

  • permanent medication with antidepressants, anticonvulsants, steroids and/or immunosuppressants

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Clinic III, Division of Endocrinology, University Clinic of Leipzig Leipzig Saxony Germany 04103

Sponsors and Collaborators

  • University of Leipzig
  • Helmholtz Institut für Metabolismus-, Adipositas- und Gefäßforschung
  • Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
  • Klinik und Poliklinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
  • Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde

Investigators

  • Study Director: Michael Stumvoll, Prof. Dr., Medical Faculty of the University of Leipzig, Leipzig, Germany
  • Principal Investigator: Imke Schamarek, Dr., Medical Faculty of the University of Leipzig, Leipzig, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imke Schamarek, Clinician Scientist, University of Leipzig
ClinicalTrials.gov Identifier:
NCT04633109
Other Study ID Numbers:
  • OTB-2020
  • DRKS00022950
First Posted:
Nov 18, 2020
Last Update Posted:
Jan 14, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imke Schamarek, Clinician Scientist, University of Leipzig
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2021