Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

This study has been terminated.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 6, 2007
Last updated: November 18, 2013
Last verified: November 2013

Evaluation of the effectiveness and the costs of a quantitative and qualitative nutritional supplementation in elderly patients

Condition Intervention Phase
Dietary Supplement: Renutryl 500
Dietary Supplement: Generique
Dietary Supplement: Generique + Renutryl 500
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Cost of a Quantitative and Qualitative Nutritional Supplementation in Elderly Patients

Resource links provided by NLM:

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Nutritional Risk Index [ Time Frame: At J0, J21, J42 ]

Secondary Outcome Measures:
  • Measure of body mass index (BMI), Mini Nutritional Assessment, Fat mass,lean mass, serum albumin and transthyretin,Activities of Daily Living (ADL), ingesta and morbidity.
  • Tolerance [ Time Frame: Daily ]

Enrollment: 63
Study Start Date: October 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: I
Active Comparator: II
oral nutrition
Dietary Supplement: Renutryl 500
Experimental: III
oral nutrition
Dietary Supplement: Generique
Experimental: IV
oral nutrition
Dietary Supplement: Generique + Renutryl 500


Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hospitalization into a geriatric care unit
  • age > 70 years
  • C reactive protein > 30 mg/l
  • 25 < albumin < 35 g/l
  • 130 < Na < 145 mmol/l
  • BMI < 22
  • weight loss > 10 % within the last 6 months
  • MNA < 23.5

Exclusion Criteria:

  • diabetes mellitus
  • severe digestive failure
  • enteral or parenteral nutrition
  • renal,cardiac or digestive failure
  • lactose intolerance
  • terminal phase severe pathology
  • MMS < 15
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560729

Hôpital Georges Clemenceau
Champcueil, France, 91750
Hopital Emile Roux
Limeil Brevannes, France, 94456
Hopital Charles RICHET
Villiers Le Bel, France, 95400
Sponsors and Collaborators
Study Director: Christian Aussel, PhD University PARIS V
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00560729     History of Changes
Other Study ID Numbers: NCNF 0402
Study First Received: November 6, 2007
Last Updated: November 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nestlé:
elderly people

ClinicalTrials.gov processed this record on April 17, 2014