Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation (VERRINES-CNO)

June 27, 2018 updated by: Centre Hospitalier Universitaire Dijon

Evaluation of a Strategy for the Presentation of Oral Nutritional Supplements (ONS) in Verrines for Managing Undernutrition in the Elderly Undergoing Follow-up Care and Geriatric Rehabilitation. Biomedical, Monocentric, Comparative, Clustered and Open Randomized Research Study

Protein-energy malnutrition results from an imbalance between the body's intake and needs. Among the elderly in long-term care, the prevalence of undernutrition varies from 30% to 70%. It is responsible for or aggravates a state of fragility or dependence, and promotes the occurrence of morbidities. It is also associated with worsening prognosis for underlying diseases and increases the risk of death. Nutritional management of undernutrition is an issue, especially in health facilities. Among the various existing nutritional care methods, oral nutritional supplements should be considered in the event of failure of food enrichment measures or even at the outset in undernourished elderly people. However, compliance or acceptance of these products among the elderly remains limited and variable with consumption of oral nutritional supplements ranging between 48% and 94% according to studies, and, because of their ease of prescription, oral supplements are sometimes the only nutritional intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients

Description

Inclusion Criteria:

  • Undernourished or at-risk individuals with blood albumin levels below 35 g/L or prealbumin levels below 200 mg/L,
  • Person admitted to geriatric follow up care less than 48 hours ago,
  • Person fed orally,
  • Person with a prescription for an ONS,
  • Person who speaks and understands French.

Exclusion Criteria:

  • Person not affiliated to a national health insurance scheme
  • Person requiring enteral or parenteral feeding
  • Person refusing to consume ONS
  • People at the very end of their lives

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Verrine
Patients served verrines
Other: Food weighing
Quantification of food intake over three consecutive days (D5, D6 and D7 then D26, D27 and D28) by weighing the food served and the leftovers at and after mealtimes.
CNO
Patients served wrapped supplements
Other: Food weighing
Quantification of food intake over three consecutive days (D5, D6 and D7 then D26, D27 and D28) by weighing the food served and the leftovers at and after mealtimes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantity of oral nutritional supplements consumed daily
Time Frame: through study completion, an average of 1 month
through study completion, an average of 1 month

Collaborators and Investigators

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

Sponsor

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 (Actual)

March 27, 2018

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAN WYMELBEKE Lactalis 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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