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

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.

Conditions

• Healthy

Interventions

OTHER

Jelly with:Paracetamol

A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses ("verrines") randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content. The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests. The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet. Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions.

OTHER

Jelly with Furosemide

OTHER

Jelly with Levothyroxine sodium salt

OTHER

Jelly with Memantine

OTHER

Jelly with Zopiclone

OTHER

Jelly with Alprazolam

OTHER

Jelly with Oxazepam

OTHER

Jelly with Donepezil

OTHER

Jelly with Clopidogrel

OTHER

Jelly with Ramipril

OTHER

Jelly with Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam

OTHER

Plain jelly control

OTHER

Apple compote Paracetamol

OTHER

Apple compote Furosemide

OTHER

Apple compote Levothyroxine sodium salt

OTHER

Apple compote Memantine

OTHER

Apple compote Zopiclone

OTHER

Apple compote Alprazolam

OTHER

Apple compote Oxazepam

OTHER

Apple compote Donepezil

OTHER

Apple compote Clopidogrel

OTHER

Apple compote Ramipril

OTHER

Apple compote + Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam

OTHER

Plain apple compote control

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2014-07-31

Completion

2014-07-31

Countries

• France

Study Locations