Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients
CNO Evaluation
1 other identifier
interventional
107
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedJune 23, 2016
May 1, 2015
9 months
June 14, 2016
June 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Acceptability of the different tested Oral Nutrition Supplement with different flavors
Hedonic scale after testing at day 2
Study Arms (2)
Cream appreciation tests
EXPERIMENTALBeverages appreciation tests
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 23, 2016
Study Start
June 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 23, 2016
Record last verified: 2015-05