Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes (PRESAGE-T2)

Lactalis

Status and phase: Completed; Phase 2

Conditions: Malnutrition

Treatments: Dietary Supplement: Standard DELICAL formula; Dietary Supplement: New DELICAL formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02117609

LRD-2011-PRESAGE

ANR ALIA2010-01306 Presage (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

New DELICAL formula

Experimental group

Description:

New high-protein oral nutrient supplement

Treatment:

Dietary Supplement: New DELICAL formula

Standard DELICAL formula

Active Comparator group

Description:

Standard isoenergetic isoprotein formula

Treatment:

Dietary Supplement: Standard DELICAL formula