CClinicalTrials.gg
Status unknownNCT04633109OTBUpdated Jan 14, 2021

The Obese Taste Bud Study

An observational study in Obesity, sponsored by University of Leipzig. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by University of Leipzig · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
210
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • food preferences
  • taste disorder
  • taste bud
  • metabolic disease
  • feeding behavior
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 210 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

the study population will mainly consits of patients who underwent a medically induced elective surgery at the head or neck area (f.e. surgery at the soft palate, plastic surgery, maintenance of congenital anomalies etc.) or healthy participants recruited elsewhere at the campus area of the Medical Faculty of the University of Leipzig, Saxony, Germany.

Inclusion criteria

  • normal weight (BMI 18.5-24.9)
  • obesity (BMI >=30)
  • overall healthy (no severe sickness, no cancer)
  • written informed consent

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
210 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 · 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

  • obese

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

    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

Interventions

  • Proceduretaste 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 testoral glucose tolerance test

    75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.

  • Diagnostic testTaste 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 testolfactory 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 testtaste 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 testanthropometry

    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.

  • Otherbiospecimen collection

    Blood and saliva samples will be taken as well as a tongue swab.

  • Otherquestionnaires

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

06

What researchers measure

Primary outcomes

  1. Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects

    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

    Time frame: through study completion, an average of 2 years

  2. Identification of correlations between taste cell biology with parameters of intervention

    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

    Time frame: 1 year

Secondary outcomes

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

    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.

    Time frame: 2 years

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

    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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Medical Clinic III, Division of Endocrinology, University Clinic of Leipzig
    Leipzig, Saxony 04103, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — one aim of this study is to obtain large-scale sequencing data. with this several not yet defined research questions will be generated which shall be explored through later analyses and projects. in order to exploit the potential of the data and to avoid misinterpretation, the data should only be accessible to the scientists and collaborators involved.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04633109
Lead sponsor
University of Leipzig
Collaborators
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
Responsible party
Imke Schamarek (Clinician Scientist, University of Leipzig) — Principal investigator
First posted
Nov 18, 2020
Start date
Nov 9, 2020
Primary completion
Jul 15, 2022 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Jan 14, 2021

Study contacts

Imke Schamarek, Dr.
Contact
Imke.Schamarek@medizin.uni-leipzig.de
+493419713803
Kerstin Rohde-Zimmermann, Dr.
Contact
Kerstin.Rohde@helmholtz-muenchen.de
+493419722932
Michael Stumvoll, Prof. Dr.
study director · Medical Faculty of the University of Leipzig, Leipzig, Germany
Imke Schamarek, Dr.
principal investigator · Medical Faculty of the University of Leipzig, Leipzig, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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