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临床试验/NCT04633109
NCT04633109Unknown不适用

The Obese Taste Bud Study

University of Leipzig1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2020年11月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
210
试验地点
1
主要终点
Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Identification of differential gene and protein regulation in isolated human taste cells between lean and obese subjects

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

发起方
University of Leipzig
申办方类型
Other
责任方
Principal Investigator
主要研究者

Imke Schamarek

Clinician Scientist

University of Leipzig

研究点 (1)

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