ObesityOTBNCT04633109
The Obese Taste Bud Study
An observational study of Obesity, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- taste bud biopsy, oral glucose tolerance test and Taste sensitivity
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2020to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- normal weight (BMI 18.5-24.9)
- obesity (BMI >=30)
- overall healthy (no severe sickness, no cancer)
- written informed consent
Who cannot join
- 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
Show all 9Show fewer
- known dysfunction of smelling or tasting
- drug or alcohol abuse
- permanent medication with antidepressants, anticonvulsants, steroids and/or immunosuppressants
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medical Clinic III, Division of Endocrinology, University Clinic of Leipzig
Leipzig, Saxony, 04103
Imke Schamarek, Dr. med., +493419713803, imke.schamarek@medizin.uni-leipzig.de
About this study
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.
- Conditions
- Obesity
- Being tested
- taste bud biopsy, oral glucose tolerance test, Taste sensitivity, olfactory function, taste bud density
- Keywords
- Obesity, food preferences, taste disorder, taste bud, metabolic disease, feeding behavior
- Medical subject headings
- Obesity, Food Preferences, Taste Disorders, Metabolic Diseases, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taste bud biopsyProcedure or surgery
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
oral glucose tolerance testDiagnostic test
75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.
Taste sensitivityDiagnostic test
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.
olfactory functionDiagnostic test
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).
taste bud densityDiagnostic test
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.
anthropometryDiagnostic test
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.
biospecimen collectionOther
Blood and saliva samples will be taken as well as a tongue swab.
questionnairesOther
Through the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| normal weight | Normal weight adults with BMI ranging from 18.5-24.9; men and women; age range 18-69years; written informed consent Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 years
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
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start9 Nov 2020
- Primary completion15 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Imke Schamarek, University of Leipzig
- Investigators
- Michael Stumvoll, Prof. Dr., Study director, Medical Faculty of the University of Leipzig, Leipzig, GermanyImke Schamarek, Dr., Principal investigator, Medical Faculty of the University of Leipzig, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633109
- Sponsor's protocol ID
- OTB-2020
- Other IDs
- DRKS00022950
- Acronym
- OTB
- Status last verified
- Jan 2021
- First submitted
- 6 Nov 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kersten A, Lorenz A, Nottmeier C, Schmidt M, Roesner A, Richter FC, Rohrborn K, Witte AV, Hahnel S, Koehne T, Bluher M, Stumvoll M, Rohde-Zimmermann K, Schamarek I. The Obese Taste Bud study: Objectives and study design. Diabetes Obes Metab. 2024 Jun;26(6):2054-2068. doi: 10.1111/dom.15563. Epub 2024 Apr 15.
PubMed 38618969
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Obese Taste Bud Study
- ClinicalTrials.gov ID
- NCT04633109
- Acronym / sponsor ID
- OTB / OTB-2020
- Conditions
- Obesity
- Keywords
- Obesity, food preferences, taste disorder, taste bud, metabolic disease, feeding behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- 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
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal weight | – | 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: questionnairesNormal weight adults with BMI ranging from 18.5-24.9; men and women; age range 18-69years; written informed consent |
| obese | – | 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: questionnairesSubjects with obesity as defined by BMI >= 30; men and women; age range 18-69 years; written informed consent |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- normal weight (BMI 18.5-24.9)
- obesity (BMI >=30)
- overall healthy (no severe sickness, no cancer)
- written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taste bud biopsyTaste 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 | Procedure or surgery | normal weight, obese |
| oral glucose tolerance test75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level. | Diagnostic test | normal weight, obese |
| Taste sensitivitySubjects 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 | normal weight, obese |
| olfactory functionSubjects 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 | normal weight, obese |
| taste bud densityThe 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 | normal weight, obese |
| anthropometryAnthropometric 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. | Diagnostic test | normal weight, obese |
| biospecimen collectionBlood and saliva samples will be taken as well as a tongue swab. | Other | normal weight, obese |
| questionnairesThrough the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained. | Other | normal weight, obese |
Primary outcome
Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects
Time frame: 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
Identification of correlations between taste cell biology with parameters of intervention
Time frame: 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
2 secondary outcomes
Differences of salivary and tongue microbiome on taste cells in obesity in contrast to lean
Time frame: 2 years
extracellular vesicle analyses of saliva in lean and obese subjects
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 38618969Kersten A, Lorenz A, Nottmeier C, Schmidt M, Roesner A, Richter FC, Rohrborn K, Witte AV, Hahnel S, Koehne T, Bluher M, Stumvoll M, Rohde-Zimmermann K, Schamarek I. The Obese Taste Bud study: Objectives and study design. Diabetes Obes Metab. 2024 Jun;26(6):2054-2068. doi: 10.1111/dom.15563. Epub 2024 Apr 15.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imke Schamarek, Dr. (+493419713803, Imke.Schamarek@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.