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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | August 24, 2005 | ||||||||||||
| Last Updated Date | November 20, 2007 | ||||||||||||
| Start Date ICMJE | November 2004 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) [ Time Frame: 42 days ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Lean mass (DEXA and BIA) at 42 days | ||||||||||||
| Change History | Complete list of historical versions of study NCT00135590 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients | ||||||||||||
| Official Title ICMJE | Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients | ||||||||||||
| 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. |
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| 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 |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE | Protein-Energy Malnutrition | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 68 | ||||||||||||
| Completion Date | October 2007 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 70 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | France | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00135590 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | PO30418, AOR03003 | ||||||||||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||||||||||
| Verification Date | November 2004 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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