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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Protein-Energy Malnutrition

Treatments: Dietary Supplement: Spread diet; Dietary Supplement: Protein pulse-feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT00135590

AOR03003

PO30418

Details and patient eligibility

About

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.

Full 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

Enrollment: 68 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

1

Experimental group

Description:

Protein pulse-feeding

Treatment:

Dietary Supplement: Protein pulse-feeding

2

Active Comparator group

Description:

Spread diet

Treatment:

Dietary Supplement: Spread diet