Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
210 participants
OBSERVATIONAL
2020-11-09
2022-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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normal weight
Normal weight adults with BMI ranging from 18.5-24.9; men and women; age range 18-69years; written informed consent
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
oral glucose tolerance test
75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.
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.
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).
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.
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.
biospecimen collection
Blood and saliva samples will be taken as well as a tongue swab.
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
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
oral glucose tolerance test
75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.
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.
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).
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.
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.
biospecimen collection
Blood and saliva samples will be taken as well as a tongue swab.
questionnaires
Through the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained.
Interventions
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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
oral glucose tolerance test
75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.
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.
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).
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.
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.
biospecimen collection
Blood and saliva samples will be taken as well as a tongue swab.
questionnaires
Through the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained.
Eligibility Criteria
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Inclusion Criteria
* obesity (BMI \>=30)
* overall healthy (no severe sickness, no cancer)
* written informed consent
Exclusion Criteria
* 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
18 Years
69 Years
ALL
Yes
Sponsors
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Helmholtz Institut für Metabolismus-, Adipositas- und Gefäßforschung
UNKNOWN
Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
UNKNOWN
Klinik und Poliklinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
UNKNOWN
Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde
UNKNOWN
University of Leipzig
OTHER
Responsible Party
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Imke Schamarek
Clinician Scientist
Principal Investigators
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Michael Stumvoll, Prof. Dr.
Role: STUDY_DIRECTOR
Medical Faculty of the University of Leipzig, Leipzig, Germany
Imke Schamarek, Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical Faculty of the University of Leipzig, Leipzig, Germany
Locations
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Medical Clinic III, Division of Endocrinology, University Clinic of Leipzig
Leipzig, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DRKS00022950
Identifier Type: REGISTRY
Identifier Source: secondary_id
OTB-2020
Identifier Type: -
Identifier Source: org_study_id
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