Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

Not Applicable

Completed

• Conditions: Protein-Energy Malnutrition
• Interventions: Dietary Supplement: Protein pulse-feeding; Dietary Supplement: Spread diet

• Registration Number: NCT00135590
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2004-11
• Study Start: 2004-11
• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-26
• Study Completion: 2007-10
• Last Update Submitted: 2007-11-20
• Last Update Posted: 2007-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Must be malnourished
• Hospitalization into a geriatric rehabilitation care unit
• Age > 70 years
• C-reactive protein (CRP) < 50 mg/l

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Exclusion Criteria

• Enteral or parenteral nutrition
• Renal, cardiac or digestive insufficiency
• Diabetes
• Pacemaker
• Mini-Mental State (MMS) < 15

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Protein pulse-feeding	Protein pulse-feeding
2	Spread diet	Spread diet

Primary Outcome Measures

Name	Time	Method
Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])	42 days

Secondary Outcome Measures

Name	Time	Method
Immune functions	42 days
Hand-grip strength	42 days
Biological nutritional parameters	42 days
Mortality and morbidity (infections and bedsores)	42 days
Activity of Daily Living (ADL)	42 days
Plasmatic amino acid levels	42 days

Trial Locations

Locations (1)

Hôpital Emile-Roux (AP-HP); 🇫🇷 Limeil-Brevannes, France