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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117609
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : October 7, 2015
Sponsor:
Collaborators:
University Hospital, Toulouse
University of Lille Nord de France
National Research Agency, France
Information provided by (Responsible Party):
Lactalis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: New DELICAL formula Dietary Supplement: Standard DELICAL formula Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : May 2012
Actual Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in 4-meter walking speed [ Time Frame: After 3 months and 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in grip strength [ Time Frame: After 3 months and 6 months ]
  2. Change from baseline in ADL (Activities Daily Living) score [ Time Frame: After 3 months and 6 months ]
  3. Change from baseline in Geriatric Depression Scale [ Time Frame: After 3 months and 6 months ]
  4. Change from baseline in quality of life (QOL-AD) [ Time Frame: After 3 months and 6 months ]
  5. Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization) [ Time Frame: During the 3 months and/or 6 months of consumption ]
  6. Change from baseline in body composition measured by bioelectrical impedence analysis (BIA) [ Time Frame: After 3 months and 6 months ]
  7. Change from baseline in nutritional status (Mini Nutritional Assessment) [ Time Frame: After 3 months and 6 months ]
  8. 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


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117609


Locations
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France
Nursing homes - Région Midi-Pyrénées
Toulouse, France
Sponsors and Collaborators
Lactalis
University Hospital, Toulouse
University of Lille Nord de France
National Research Agency, France
Investigators
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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
More Information
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Responsible Party: Lactalis
ClinicalTrials.gov Identifier: NCT02117609    
Other Study ID Numbers: LRD-2011-PRESAGE
ANR ALIA2010-01306 Presage ( Other Grant/Funding Number: National Research Organization, France )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by Lactalis:
Elderly
Nursing home
Functional impairment
High-protein oral supplement
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders