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

Phase 2

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: New DELICAL formula; Dietary Supplement: Standard DELICAL formula

• Registration Number: NCT02117609
• Lead Sponsor: Lactalis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Primary Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New DELICAL formula	New DELICAL formula	New high-protein oral nutrient supplement
Standard DELICAL formula	Standard DELICAL formula	Standard isoenergetic isoprotein formula

Primary Outcome Measures

Name	Time	Method
Change from baseline in 4-meter walking speed	After 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Geriatric Depression Scale	After 3 months and 6 months
Change from baseline in grip strength	After 3 months and 6 months
Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)	After 3 months and 6 months
Change from baseline in nutritional status (Mini Nutritional Assessment)	After 3 months and 6 months
Change from baseline in ADL (Activities Daily Living) score	After 3 months and 6 months
Change from baseline in quality of life (QOL-AD)	After 3 months and 6 months
Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)	During the 3 months and/or 6 months of consumption
Changes from baseline in blood parameters	After 3 months and 6 months	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

Trial Locations

Locations (1)

Nursing homes - Région Midi-Pyrénées; 🇫🇷 Toulouse, France