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

Patients Hospitalized in Follow up Care or Rehabilitation Clinical Trial

— VERRINES-CNO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03582358
• Other study ID #: VAN WYMELBEKE Lactalis 2017
• Status: Recruiting
• Start date: March 27, 2018
• Est. completion date: April 2020

Study information

• Verified date: June 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Patrick MANCKOUNDIA
• Phone: 0380295844
• Email: patrick.manckoundia[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Patients Hospitalized in Follow up Care or Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of oral nutritional supplements consumed daily		through study completion, an average of 1 month