Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients

Malnutrition Clinical Trial

— CNO Evaluation  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810470
• Other study ID #: VAN WYMELBEKE NUTRICIA 2015
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 20, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2015
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Fortimel Compact Protein
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the different tested Oral Nutrition Supplement with different flavors		Hedonic scale after testing at day 2	No