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Clinical Trials/NCT04633109
NCT04633109
Unknown
Not Applicable

The Obese Taste Bud Study

University of Leipzig1 site in 1 country210 target enrollmentNovember 9, 2020
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Leipzig
Enrollment
210
Locations
1
Primary Endpoint
Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 9, 2020
End Date
July 30, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Leipzig
Responsible Party
Principal Investigator
Principal Investigator

Imke Schamarek

Clinician Scientist

University of Leipzig

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Sites (1)

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