Protein-Energy Malnutrition Clinical Trial
— PRO-PULSéOfficial title:
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Verified date | November 2004 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | October 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Emile-Roux (AP-HP) | Limeil-Brevannes |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) | 42 days | ||
Secondary | Immune functions | 42 days | ||
Secondary | Hand-grip strength | 42 days | ||
Secondary | Biological nutritional parameters | 42 days | ||
Secondary | Mortality and morbidity (infections and bedsores) | 42 days | ||
Secondary | Activity of Daily Living (ADL) | 42 days | ||
Secondary | Plasmatic amino acid levels | 42 days |
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