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Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients (CNO Evaluation)

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ClinicalTrials.gov Identifier: NCT02810470
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Fortimel Compact Protein Dietary Supplement: Fortimel Cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients Aged for More Than 65 Years
Study Start Date : June 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cream appreciation tests 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.

Dietary Supplement: 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.

Experimental: Beverages appreciation tests 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.

Dietary Supplement: 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.




Primary Outcome Measures :
  1. Acceptability of the different tested Oral Nutrition Supplement with different flavors [ Time Frame: Hedonic scale after testing at day 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02810470    
Other Study ID Numbers: VAN WYMELBEKE NUTRICIA 2015
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: May 2015
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders