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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135590

Acronym

PRO-PULSé

Enrollment

Registered

2005-08-26

Start date

2004-11-30

Completion date

2007-10-31

Last updated

2007-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein-Energy Malnutrition

Keywords

Protein pulse-feeding, Nutritional supplementation, Protein-energy malnutrition, Elderly subjects, Body composition

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

Interventions

DIETARY_SUPPLEMENTProtein pulse-feeding

Dietary protein (80% of daily intake) was consumed in one meal (12.00h)

DIETARY_SUPPLEMENTSpread diet

Dietary protein was spread over the four meals.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026