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

June 20, 2016 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Acceptability of the different tested Oral Nutrition Supplement with different flavors
Time Frame: Hedonic scale after testing at day 2
Hedonic scale after testing at day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAN WYMELBEKE NUTRICIA 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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