Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes

Malnutrition Clinical Trial

— PRESAGE-T2  

Official title:

Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117609
• Other study ID #: LRD-2011-PRESAGE
• Secondary ID: ANR ALIA2010-013
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2014
• Last updated: October 6, 2015
• Start date: May 2012

Study information

• Verified date: October 2015
• Source: Lactalis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Man or woman aged more than 60 years old

• Living in a nursing home for at least 2 months

• Malnourished or at risk of malnutrition (MNA<23.5 or BMI<24 or albumin<35 g/l or weight loss of more than 5 kg in the last 6 months)

• Without dementia or with moderate dementia (MMSE > or =10/30)

• Able to walk without human assistance (technical assistance allowed)

• No vitamin D supplementation

• Able to follow the study procedures and agreed to consume oral supplement

Exclusion Criteria:

• Severe dementia (MMSE < 10/30)

• Enteral nutrition

• Severe renal or hepatic impairment

• Cancer with chemotherapy

• Uncontrolled diabetes

• Lactose intolerance

• Cow's milk protein allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• New DELICAL formula
3 months with the option of continuing until 6 months.
• Standard DELICAL formula
3 months with the option of continuing until 6 months.

Locations

Country	Name	City	State
France	Nursing homes - Région Midi-Pyrénées	Toulouse

Sponsors (4)

Lead Sponsor	Collaborator
Lactalis	National Research Agency, France, University Hospital, Toulouse, University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in 4-meter walking speed		After 3 months and 6 months	No
Secondary	Change from baseline in grip strength		After 3 months and 6 months	No
Secondary	Change from baseline in ADL (Activities Daily Living) score		After 3 months and 6 months	No
Secondary	Change from baseline in Geriatric Depression Scale		After 3 months and 6 months	No
Secondary	Change from baseline in quality of life (QOL-AD)		After 3 months and 6 months	No
Secondary	Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)		During the 3 months and/or 6 months of consumption	No
Secondary	Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)		After 3 months and 6 months	No
Secondary	Change from baseline in nutritional status (Mini Nutritional Assessment)		After 3 months and 6 months	No
Secondary	Changes from baseline in blood parameters	Inflammation markers (TNFalpha, TNF-R1, TNF-R2, IL 15), Fatty acid composition of red blood cell membranes, Fibrinogen, CRP, albumin, prealbumin, orosomucoid, IGF-1, cystein, glutathione peroxidase, oxidized and reduced glutathione	After 3 months and 6 months	No