Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cheese Products in Elderly People
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- calculation of insanity rate
研究概览
简要总结
The aim of this study is to understand how dairy products enriched in minerals and proteins are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and formation of the food bolus during the consumption of enriched cheese, that is to say the way in which the food is broken down to be swallowed.
The study will take place at the INRA in Dijon during 2 one-hour sessions spread over 4 months. These two sessions will allow investigators to characterise the chewing behaviour of the subjects and their salivation, and the structure of the food bolus formed when eating the four products of the project.
For each of the four foods in each session:
- Two samples of saliva will be taken
- A video will be made of subjects eating one of the study products
- Subjects will chew the study foods and spit them out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Persons who have provided written consent
- •Age ≥ 65 years old
- •Persons living at home
- •Persons who can travel independently
排除标准
- •Adults under guardianship
- •Persons without health insurance cover
- •Persons in hospital
- •Persons in institutions
- •Persons whose Mini-Mental State Examination (MMSE) is < 24
- •Persons requiring enteral or parenteral nutrition
- •Persons who in the previous 12 months received € 4500 for taking part in clinical trials, including the present study
- •Persons in a period of exclusion of a previous study
- •Food allergies (dairy products in particular)
研究组 & 干预措施
Good chewing ability
干预措施: Two samples of saliva (Other)
Good chewing ability
干预措施: Chewing behaviour (Other)
Good chewing ability
干预措施: Study of the food bolus (Other)
Impaired chewing ability
干预措施: Two samples of saliva (Other)
Impaired chewing ability
干预措施: Chewing behaviour (Other)
Impaired chewing ability
干预措施: Study of the food bolus (Other)
结局指标
主要结局
calculation of insanity rate
时间窗: Change from baseline at 4 months
Frequency of chewing
时间窗: Change from baseline at 4 months
Rheology test
时间窗: Change from baseline at 4 months
Duration of chewing
时间窗: Change from baseline at 4 months
次要结局
未报告次要终点