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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00135590 |
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 |
MedlinePlus related topics: | Dietary Supplements |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients |
Enrollment: | 68 |
Study Start Date: | November 2004 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
1: Experimental
Protein pulse-feeding
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Dietary Supplement: Protein pulse-feeding
Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
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2: Active Comparator
Spread diet
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Dietary Supplement: Spread diet
Dietary protein was spread over the four meals.
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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
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
Hôpital Emile-Roux (AP-HP) | |||||
Limeil-Brevannes, France, 94456 |
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) |
Study ID Numbers: | PO30418, AOR03003 |
First Received: | August 24, 2005 |
Last Updated: | November 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00135590 |
Health Authority: | France: Ministry of Health |
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