Clinical trial NCT04633109: The Obese Taste Bud Study
Official title: The Obese Taste Bud Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Obesity
food preferences
taste disorder
taste bud
metabolic disease
feeding behavior
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Helmholtz Institut für Metabolismus-, Adipositas- und Gefäßforschung
name: Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
name: Klinik und Poliklinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
name: Poliklinik für Zahnärztliche Prothetik und Werkstoffkunde
First posted: 2020-11-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects
timeFrame: through study completion, an average of 2 years
measure: Identification of correlations between taste cell biology with parameters of intervention
timeFrame: 1 year
Secondary outcomes:
measure: Differences of salivary and tongue microbiome on taste cells in obesity in contrast to lean
timeFrame: 2 years
measure: extracellular vesicle analyses of saliva in lean and obese subjects
timeFrame: 2 years
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Medical Clinic III, Division of Endocrinology, University Clinic of Leipzig
state: Saxony
Study officials:
affiliation: Medical Faculty of the University of Leipzig, Leipzig, Germany
name: Michael Stumvoll, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Medical Faculty of the University of Leipzig, Leipzig, Germany
name: Imke Schamarek, Dr.
role: PRINCIPAL_INVESTIGATOR
References: