Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients

Malnutrition is a major health problem with serious consequences for the quality of life of elderly people: it increases the number of hospitalizations and lengths of stay, worsens functional dependency and increases morbidity and mortality rates There are numerous recommendations and tools to detect or to manage malnutrition and the prescription of Oral Nutritional Supplements (ONS) can be a solution. As the elderly suffer from food monotony, as well as age-related changes, which may or may not be associated with the presence of disease, it is necessary to ensure full ingestion of the prescribed supplements to optimize the benefits provided by these products. To achieve this it is necessary to know the chemosensory characteristics of foods enjoyed by hospitalized elderly people who are malnourished or at risk of malnutrition. The investigators make the hypothesis that by further optimizing taste and energy content of foods, consumption by the elderly and the health benefits would be improved.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Person who have given their written informed consent
Person aged more than 65 years
Person cognitively able to participate in tests and to answer questionnaires (Mini Mental Statement Estimation score (MMSE) equal to or greater than 21)
Person with an Mini Nutritional Status score (MNA) lower than 23.5/30 for risk of malnutrition or malnourished
Person without known unstable cardiac disease
Person without high blood pressure

Exclusion criteria

Person who are not covered by national health insurance
Person suffering from severe illness during the test
Person with a life expectancy lower than 6 months or with a cancer
Every person with proven anosmia (total loss of olfaction) from birth or due to physical trauma (head trauma) or disease (acute rhinitis)
Person with allergy (soya milk) or severe aversion to one of the foods that will be used during the study
Person with swallowing disorders
Person with a prescribed strict food diet
Person with an instable diabetes

Treatment and study plan

Fortimel Compact Protein

Dietary Supplement

Each product will be tested by all patients spread over 2 days. A first half of volunteers will start the testing process with the beverages at day 1 and continue with the creams at day 2. The second half of volunteers will process inversely (day 1 = creams, day 2 = beverages). The test order of flavors will be randomly allocated to the volunteers among the list of all possible combinations.

Fortimel Cream

Dietary Supplement

Primary outcomes

Acceptability of the different tested Oral Nutrition Supplement with different flavors

Time frame: Hedonic scale after testing at day 2

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients Aged for More Than 65 Years

Acronym: CNO Evaluation

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 23, 2016
Registry last updated: Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed