The Obese Taste Bud Study

NCT ID: NCT04633109

Last Updated: 2021-01-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-09

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type DIAGNOSTIC_TEST

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

Taste sensitivity

Intervention Type DIAGNOSTIC_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 function

Intervention Type DIAGNOSTIC_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 density

Intervention Type DIAGNOSTIC_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.

anthropometry

Intervention Type DIAGNOSTIC_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 collection

Intervention Type OTHER

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

questionnaires

Intervention Type OTHER

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

Intervention Type PROCEDURE

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

Intervention Type DIAGNOSTIC_TEST

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

Taste sensitivity

Intervention Type DIAGNOSTIC_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 function

Intervention Type DIAGNOSTIC_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 density

Intervention Type DIAGNOSTIC_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.

anthropometry

Intervention Type DIAGNOSTIC_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 collection

Intervention Type OTHER

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

questionnaires

Intervention Type OTHER

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

Intervention Type PROCEDURE

oral glucose tolerance test

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

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

biospecimen collection

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

Intervention Type OTHER

questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helmholtz Institut für Metabolismus-, Adipositas- und Gefäßforschung

UNKNOWN

Sponsor Role collaborator

Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

UNKNOWN

Sponsor Role collaborator

Klinik und Poliklinik für Mund-, Kiefer- und Plastische Gesichtschirurgie

UNKNOWN

Sponsor Role collaborator

Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde

UNKNOWN

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Imke Schamarek

Clinician Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Imke Schamarek, Dr.

Role: CONTACT

+493419713803

Kerstin Rohde-Zimmermann, Dr.

Role: CONTACT

+493419722932

Facility Contacts

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Imke Schamarek, Dr. med.

Role: primary

+493419713803

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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