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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT02570581
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

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.

Criteria of evaluation:

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

2. Qualitative: description of the perceived aroma (acid, bitter, sweet, salty, astringent, pricking, aromatic).

Brief description of the methodology:

The investigator shall test 10 drugs the most prescribed in the Korian group nursing homes, identified as being able to be crushed or opened. The assay will take place during a single one-morning session in a room specifically dedicated to clinical assays and with the help of a nursing staff trained for clinical assays (Nice University Hospital). Medicine will be crushed in parallel in some jelly and apple compote: 10 single drugs, 1 mixture of 6 drugs and 1 comparator (unmodified plain jelly and compote). Every volunteer will make these 24 tests blind and will fill a scoring sheet. He or she will spit out and have an oral rinse with some water between two tests; the dose susceptible to be ingested will be about 1/500th of a unit dosage. Excepted a risk of allergy, the medical risk is thus unimportant for the tasters. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions.

Individual duration of the study. One morning. Total duration of the study. One year and half, for the organization of the test and the publication of the results.

Expected fallout

* The fight against senile anorexia and malnutrition, in elderly people who are given polypharmacy, by improving care protocols.

* Proposal of alternative solutions such as pediatric or galenic forms if they exist, other food substrates or new additives which would allow to mask the taste of certain drugs crushed in food.

* Incitement in a policy of reduction of drugs for the elderly.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-10-06
• Last Update Submitted: 2015-10-06
• Study First Posted: 2015-10-07
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• healthy volunteers over 18 years.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quantitative- compare the taste between specimens	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.

Secondary Outcome Measures

Name	Time	Method
qualitative - description of the perceived aroma	1 week after the test	Qualitative: description of the perceived aroma (acid, bitter, sweet, salty, astringent, pricking, aromatic).

Trial Locations

Locations (1)

Center for Clinical Research - Archet 1 Hospital Nice Hospital; 🇫🇷 Nice, France