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
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
- 否
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
研究点 (2)
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