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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:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00135590
First received: August 24, 2005
Last updated: November 20, 2007
Last verified: November 2004
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: August 24, 2005
Last Updated: November 20, 2007
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013