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

Lactalis110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

110

Conditions

Malnutrition

Interventions

New DELICAL formulaDIETARY_SUPPLEMENT

3 months with the option of continuing until 6 months.

Standard DELICAL formulaDIETARY_SUPPLEMENT

3 months with the option of continuing until 6 months.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nursing homes - Région Midi-Pyrénées

Toulouse, France