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Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients (PRO-PULSé)
This study has been completed.
Study NCT00135590   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: August 24, 2005   Last Updated: November 20, 2007   History of Changes

August 24, 2005
November 20, 2007
November 2004
 
Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) [ Time Frame: 42 days ]
Lean mass (DEXA and BIA) at 42 days
Complete list of historical versions of study NCT00135590 on ClinicalTrials.gov Archive Site
  • Immune functions [ Time Frame: 42 days ]
  • Hand-grip strength [ Time Frame: 42 days ]
  • Biological nutritional parameters [ Time Frame: 42 days ]
  • Mortality and morbidity (infections and bedsores) [ Time Frame: 42 days ]
  • Activity of Daily Living (ADL) [ Time Frame: 42 days ]
  • Plasmatic amino acid levels [ Time Frame: 42 days ]
  • Immune functions at 42 days
  • Hand-grip strength at 42 days
  • Biological nutritional parameters at 42 days
  • Mortality and morbidity (infections and bedsores) at 42 days
  • Activity of Daily Living (ADL) at 42 days
  • Plasmatic amino acids levels
 
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.

To estimate the amelioration of the accretion in protein and the immunizing deficit thanks to a nutrition "PULSEE" ( to hold on 80 % of the proteic by day in on meal) with a proteic distributed all along the day for old subjects having a denutrition

To also estimate that the diminution of the morbidity decrease (infections, bedsores) the average during the stay and the mortality according to 2 modalities of grip nutritional

 
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Protein-Energy Malnutrition
  • Dietary Supplement: Protein pulse-feeding
  • Dietary Supplement: Spread diet
  • Experimental: Protein pulse-feeding
  • Active Comparator: Spread diet
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
68
October 2007
 

Inclusion Criteria:

  • Must be malnourished
  • Hospitalization into a geriatric rehabilitation care unit
  • Age > 70 years
  • C-reactive protein (CRP) < 50 mg/l

Exclusion Criteria:

  • Enteral or parenteral nutrition
  • Renal, cardiac or digestive insufficiency
  • Diabetes
  • Pacemaker
  • Mini-Mental State (MMS) < 15
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00135590
 
PO30418, AOR03003
Assistance Publique - Hôpitaux de Paris
 
Study Director: Aussel Christian, PHD, PharmD Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile Roux (AP-HP)
Study Chair: Cynober Luc, PHD, PharmD Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Hôtel-Dieu (AP-HP)
Principal Investigator: Bouillanne Olivier, MD Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile-Roux (AP-HP)
Assistance Publique - Hôpitaux de Paris
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP