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

Protein-Energy Malnutrition Clinical Trial

— PRO-PULSé  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135590
• Other study ID #: PO30418
• Secondary ID: AOR03003
• Status: Completed
• Phase: N/A
• First received: August 24, 2005
• Last updated: November 20, 2007
• Start date: November 2004
• Est. completion date: October 2007

Study information

• 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

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2007
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Protein-Energy Malnutrition

Intervention

Dietary Supplement:
• Protein pulse-feeding
Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
• Spread diet
Dietary protein was spread over the four meals.

Locations

Country	Name	City	State
France	Hôpital Emile-Roux (AP-HP)	Limeil-Brevannes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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