search
Back to results

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

Primary Purpose

Malnutrition

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
New DELICAL formula
Standard DELICAL formula
Sponsored by
Lactalis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Elderly, Nursing home, Functional impairment, High-protein oral supplement

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Nursing homes - Région Midi-Pyrénées

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

New DELICAL formula

Standard DELICAL formula

Arm Description

New high-protein oral nutrient supplement

Standard isoenergetic isoprotein formula

Outcomes

Primary Outcome Measures

Change from baseline in 4-meter walking speed

Secondary Outcome Measures

Change from baseline in grip strength
Change from baseline in ADL (Activities Daily Living) score
Change from baseline in Geriatric Depression Scale
Change from baseline in quality of life (QOL-AD)
Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)
Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)
Change from baseline in nutritional status (Mini Nutritional Assessment)
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

Full Information

First Posted
April 16, 2014
Last Updated
October 6, 2015
Sponsor
Lactalis
Collaborators
University Hospital, Toulouse, University of Lille Nord de France, National Research Agency, France
search

1. Study Identification

Unique Protocol Identification Number
NCT02117609
Brief Title
Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lactalis
Collaborators
University Hospital, Toulouse, University of Lille Nord de France, National Research Agency, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Elderly, Nursing home, Functional impairment, High-protein oral supplement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New DELICAL formula
Arm Type
Experimental
Arm Description
New high-protein oral nutrient supplement
Arm Title
Standard DELICAL formula
Arm Type
Active Comparator
Arm Description
Standard isoenergetic isoprotein formula
Intervention Type
Dietary Supplement
Intervention Name(s)
New DELICAL formula
Intervention Description
3 months with the option of continuing until 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard DELICAL formula
Intervention Description
3 months with the option of continuing until 6 months.
Primary Outcome Measure Information:
Title
Change from baseline in 4-meter walking speed
Time Frame
After 3 months and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in grip strength
Time Frame
After 3 months and 6 months
Title
Change from baseline in ADL (Activities Daily Living) score
Time Frame
After 3 months and 6 months
Title
Change from baseline in Geriatric Depression Scale
Time Frame
After 3 months and 6 months
Title
Change from baseline in quality of life (QOL-AD)
Time Frame
After 3 months and 6 months
Title
Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)
Time Frame
During the 3 months and/or 6 months of consumption
Title
Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)
Time Frame
After 3 months and 6 months
Title
Change from baseline in nutritional status (Mini Nutritional Assessment)
Time Frame
After 3 months and 6 months
Title
Changes from baseline in blood parameters
Description
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
Time Frame
After 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Rolland, Pr
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cécile Bonhomme, PhD
Organizational Affiliation
Lactalis Nutrition Santé
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Seguy, Dr
Organizational Affiliation
U995, Université Lille Nord France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charlotte Baudry, PhD
Organizational Affiliation
Lactalis Recherche et Développement
Official's Role
Study Chair
Facility Information:
Facility Name
Nursing homes - Région Midi-Pyrénées
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs