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

October 6, 2015 updated by: Lactalis

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Nursing homes - Région Midi-Pyrénées

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New DELICAL formula
New high-protein oral nutrient supplement
Dietary supplement: New DELICAL formula
3 months with the option of continuing until 6 months.
Active Comparator: Standard DELICAL formula
Standard isoenergetic isoprotein formula
Dietary supplement: Standard DELICAL formula
3 months with the option of continuing until 6 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lactalis

Collaborators

University Hospital, Toulouse
National Research Agency, France
University of Lille Nord de France

Investigators

  • Principal Investigator: Yves Rolland, Pr, University Hospital, Toulouse
  • Study Director: Cécile Bonhomme, PhD, Lactalis Nutrition Santé
  • Study Chair: David Seguy, Dr, U995, Université Lille Nord France
  • Study Chair: Charlotte Baudry, PhD, Lactalis Recherche et Développement

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRD-2011-PRESAGE
  • ANR ALIA2010-01306 Presage (Other Grant/Funding Number: National Research Organization, France)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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