The Obese Taste Bud Study

NCT04633109 | Unknown

• 2 other identifiers: OTB-2020DRKS00022950
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; food preferences; taste disorder; taste bud; metabolic disease; feeding behavior

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 year

Secondary Outcomes (2)

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

  2 years

• extracellular vesicle analyses of saliva in lean and obese subjects

  2 years

Study Arms (2)

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

taste bud biopsy 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

normal weight; obese

oral glucose tolerance test DIAGNOSTIC_TEST

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

normal weight; obese

Taste sensitivity 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.

normal weight; obese

olfactory function 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).

normal weight; obese

taste bud density 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.

normal weight; obese

anthropometry 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.

normal weight; obese

biospecimen collection OTHER

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

normal weight; obese

questionnaires OTHER

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

normal weight; obese

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Medical Clinic III, Division of Endocrinology, University Clinic of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Taste buds, saliva, blood

MeSH Terms

Conditions

Obesity; Food Preferences; Taste Disorders; Metabolic Diseases; Feeding Behavior

Interventions

Glucose Tolerance Test; Anthropometry; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Behavior, Animal

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Physical Examination; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Stumvoll, Prof. Dr.

  Medical Faculty of the University of Leipzig, Leipzig, Germany

  STUDY DIRECTOR

• Imke Schamarek, Dr.

  Medical Faculty of the University of Leipzig, Leipzig, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imke Schamarek, Dr.

CONTACT

+493419713803; Imke.Schamarek@medizin.uni-leipzig.de

Kerstin Rohde-Zimmermann, Dr.

CONTACT

+493419722932; Kerstin.Rohde@helmholtz-muenchen.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 18, 2020
• Study Start: November 9, 2020
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)