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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02117609

Acronym

PRESAGE-T2

Enrollment

110

Registered

2014-04-21

Start date

2012-05-31

Completion date

Unknown

Last updated

2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Elderly, Nursing home, Functional impairment, High-protein oral supplement

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.

Interventions

DIETARY_SUPPLEMENTNew DELICAL formula

3 months with the option of continuing until 6 months.

DIETARY_SUPPLEMENTStandard DELICAL formula

3 months with the option of continuing until 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in 4-meter walking speed	After 3 months and 6 months

Secondary

Measure	Time frame	Description
Change from baseline in ADL (Activities Daily Living) score	After 3 months and 6 months	—
Change from baseline in Geriatric Depression Scale	After 3 months and 6 months	—
Change from baseline in quality of life (QOL-AD)	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	—
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
Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)	During the 3 months and/or 6 months of consumption	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026