跳至主要内容
临床试验/NCT02825407
NCT02825407Unknown不适用

Creation et Characterization of Two Groups of Elderly Subjects so as to Evaluate the Link Between the Characteristics of Oral Physiology, Sensory Sensitivity, the Release in Vivo Aromatic Compounds, and In-mouth Comfort During the Consumption of Foods

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
试验地点
2
主要终点
Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index

研究概览

简要总结

There are few data on elderly people concerning mechanisms involved in the in vivo release and perception of aromatic compounds. Any knowledge on this point would be of great interest to the scientific community. Concerning the dimensions of sensory perception and in-mouth comfort, there is, to our knowledge, no methodology to describe them. These dimensions are truly original and innovative, and investigating them will lead to the development of foods adapted to elderly populations with chewing and salivation disorders.

The expected results are:

  • to obtain two groups of subjects with differences in chewing abilities and saliva production
  • the characterization of flavour release profiles in elderly subjects with regard to oral physiology (mastication and salivation) and saliva composition
  • a sensory profile describing in-mouth comfort when food is eaten

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons who have provided written consent
  • Age >= 65 years
  • Persons living at home or in an old-people's home (Etablissement Hébergement Personnes Agées Dépendantes : EHPAD)
  • Persons able to move around independently

排除标准

  • Persons without national health insurance cover
  • Persons in hospital
  • Persons whose MMSE (Mini-Mental State Examination) is < 24
  • Persons requiring enteral or parenteral feeding
  • Persons who in the last 12 months have received € 4500 by participating in clinical studies, including the present study
  • Persons in a period of exclusion following a previous study
  • Food allergies
  • Adults under guardianship

结局指标

主要结局

Dental health evaluation : GOHAI questionnaire (Geriatric Oral Health Assessment Index

时间窗: At inclusion

次要结局

  • Measure of chewing efficacy : fast test of chewing, Masticatory Normality Index (MNI)(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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