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

NCT ID: NCT03582358

Last Updated: 2018-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-27

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients Hospitalized in Follow up Care or Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Verrine

Patients served verrines

Food weighing

Intervention Type OTHER

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

Food weighing

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Patrick MANCKOUNDIA

Role: CONTACT

0380295844

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patrick MANCKOUNDIA

Role: primary

0380295844

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VAN WYMELBEKE Lactalis 2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Food Intake in Older Patients
NCT02490761 COMPLETED