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Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients (PRO-PULSé)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00135590
First Posted: August 26, 2005
Last Update Posted: November 22, 2007
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.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Protein-Energy Malnutrition Dietary Supplement: Protein pulse-feeding Dietary Supplement: Spread diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) [ Time Frame: 42 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 68
Study Start Date: November 2004
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
Protein pulse-feeding
Dietary Supplement: Protein pulse-feeding
Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
Active Comparator: 2
Spread diet
Dietary Supplement: Spread diet
Dietary protein was spread over the four meals.

Detailed Description:

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

  Eligibility

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00135590


Locations
France
Hôpital Emile-Roux (AP-HP)
Limeil-Brevannes, France, 94456
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00135590     History of Changes
Other Study ID Numbers: PO30418
AOR03003
First Submitted: August 24, 2005
First Posted: August 26, 2005
Last Update Posted: November 22, 2007
Last Verified: November 2004

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Protein pulse-feeding
Nutritional supplementation
Protein-energy malnutrition
Elderly subjects
Body composition

Additional relevant MeSH terms:
Malnutrition
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases