临床试验/NCT02570581

NCT02570581已完成1 期

MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers

Centre Hospitalier Universitaire de Nice1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2014年6月1日最近更新: 2015年10月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Centre Hospitalier Universitaire de Nice
入组人数: 16
试验地点: 1
主要终点: Quantitative- compare the taste between specimens

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Elderly people often suffer from chronic pathologies and they are given polypharmacy. In case of swallowing problems, the drugs are crushed and mixed in food, which alters the taste of food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs have nether been investigated. The MELA study is a one session hedonic test involving 16 healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8 food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they will have a unique opportunity to communicate and propose solutions to this neglected aspect of malnutrition in elderly populations.

详细描述

Background. Elderly people often suffer from chronic pathologies and they are given polypharmacy. In nursing homes, the residents take an average number of 6 to 8 active principles / day (Reference Geriatrics ward, Nice University Hospital, France), the equivalent of 10 to 20 medicines / day. But 40 % of the residents have swallowing disorders or cognitive impairment: the nursing staff is obliged to crush tablets and capsules and to give them mixed in a compote, a dairy or a jelly, for instance. Some experts groups (OMEDIT) have published a list of drugs authorized to be crushed, because this practice can modify the pharmacokinetics of certain active principles, and render them inactive or even toxic. However, the gustative aspect of crushed drugs has never been investigated.

Main objective. To identify from the advice of healthy volunteers, on the gustative aspect, which medicine it is acceptable or not recommended to add once crushed or opened in food.

Secondary objective. To search for alternative solutions. Type of study. Phase I study on healthy volunteers. It is a cohort study, with a hedonic, descriptive test in a single group and a single one session, to test the taste of 10 drugs crushed in some jelly and apple compote.

Volunteers participating in the study will be 16 healthy volunteers: 8 professionals of the restaurant, the catering, the food aromas, the nutrition and the dietetics, and 8 doctors, pharmacists, dental surgeons, nurses and/or nurse's aides.

Inclusion criteria: healthy volunteers over 18 years, without allergy known about 10 drugs to be tested. Pregnant women will not be included.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Health Services Research
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•healthy volunteers over 18 years.

排除标准

•pregnant women. Women in age to borne children will perform a urinary test will just before the assay, under the supervision of the Clinical Research Center nurse.

Active Comparator

Apple Paracetamol Furosemide Levothyroxine NACL Memantine Zopiclone Alprazolam

干预措施: Apple compote Zopiclone (Other)

结局指标

主要结局

Quantitative- compare the taste between specimens

时间窗: 1 week after the test

Quantitative: mark from 0 (bad taste) to 10 (no taste or no unpleasant taste) for the jelly and compote specimens added with crushed drugs.

次要结局

qualitative - description of the perceived aroma(1 week after the test)

研究者

发起方

Centre Hospitalier Universitaire de Nice

申办方类型

Other

责任方

Sponsor

研究点 (1)

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