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临床试验/NCT03227887
NCT03227887已完成不适用

Evaluation of the Link Between the Characteristics of Oral Physiology and Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People Via a Modelling Approach.

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Duration of chewing during consumption of cereal products

研究概览

简要总结

The aim of this study is to understand how foods such as Sponge cake or Brioche are broken down in the mouth. More specifically, investigators wish to evaluate the link between oral physiology (salivation and mastication) and (i) formation of the food bolus during the consumption of Sponge cake or Brioche, that is to say the way in which the food is broken down to be swallowed (ii) mouthfeel during the consumption of Sponge cake or Brioche, meaning the sensations that participant feel when they eat these products.

The study will take place at the INRA in Dijon during 7 one-hour sessions spread over 3 months. The first session will allow us to characterise the chewing behaviour of the subjects and their salivation, and will enable us to train them in the instructions for the following sessions. The 6 other sessions will allow us to study the structure of the food bolus while being formed and the mouthfeel of the foods in the project.

In the first session:

  • Two samples of saliva will be taken
  • A video will be made of subjects eating Sponge cake or Brioche
  • Subjects will be trained in exercises for the following sessions - this will consist in chewing the study foods and spitting them out on the experimenter's signal.

During the 6 other sessions, subjects will be asked to:

  • Chew one of the study foods and spit it out on the signal of the experimenter.
  • Evaluate the mouthfeel while eating Sponge cake or Brioche by answering different questions. This test will be done during 4 of the 6 sessions.

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

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 (cereal products in particular)

研究组 & 干预措施

Impaired chewing ability

Experimental

干预措施: Two samples of saliva (Other)

Impaired chewing ability

Experimental

干预措施: Chewing behaviour (Other)

Impaired chewing ability

Experimental

干预措施: Study of the food bolus (Other)

Impaired chewing ability

Experimental

干预措施: Mouthfeel (Other)

Good chewing ability

Active Comparator

干预措施: Two samples of saliva (Other)

Good chewing ability

Active Comparator

干预措施: Chewing behaviour (Other)

Good chewing ability

Active Comparator

干预措施: Study of the food bolus (Other)

Good chewing ability

Active Comparator

干预措施: Mouthfeel (Other)

结局指标

主要结局

Duration of chewing during consumption of cereal products

时间窗: At baseline

Rheology test

时间窗: Up to 3 months

Frequency of chewing during consumption of cereal products

时间窗: At baseline

Calculation of insalivation rates

时间窗: Up to 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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