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

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ClinicalTrials.gov Identifier: NCT00135590
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : November 22, 2007
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Protein-Energy Malnutrition Dietary Supplement: Protein pulse-feeding Dietary Supplement: Spread diet Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
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
Study Start Date : November 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  1. Immune functions [ Time Frame: 42 days ]
  2. Hand-grip strength [ Time Frame: 42 days ]
  3. Biological nutritional parameters [ Time Frame: 42 days ]
  4. Mortality and morbidity (infections and bedsores) [ Time Frame: 42 days ]
  5. Activity of Daily Living (ADL) [ Time Frame: 42 days ]
  6. Plasmatic amino acid levels [ Time Frame: 42 days ]


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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

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)

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 Posted: August 26, 2005    Key Record Dates
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