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Clinical Trials/NCT04633109
NCT04633109UnknownNot Applicable

The Obese Taste Bud Study

University of Leipzig1 site in 1 country210 target enrollmentStarted: November 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
210
Locations
1
Primary Endpoint
Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor
University of Leipzig
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Imke Schamarek

Clinician Scientist

University of Leipzig

Study Sites (1)

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