Clinical trial NCT00135590: Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Official title: Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein-Energy Malnutrition
Keywords: Protein pulse-feeding
Nutritional supplementation
Protein-energy malnutrition
Elderly subjects
Body composition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 68
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])
timeFrame: 42 days
Secondary outcomes:
measure: Immune functions
timeFrame: 42 days
measure: Hand-grip strength
timeFrame: 42 days
measure: Biological nutritional parameters
timeFrame: 42 days
measure: Mortality and morbidity (infections and bedsores)
timeFrame: 42 days
measure: Activity of Daily Living (ADL)
timeFrame: 42 days
measure: Plasmatic amino acid levels
timeFrame: 42 days
Other outcomes:
Locations:
city: Limeil-Brevannes
country: France
facility: Hôpital Emile-Roux (AP-HP)
Study officials:
affiliation: Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile Roux (AP-HP)
name: Aussel Christian, PHD, PharmD
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Hôtel-Dieu (AP-HP)
name: Cynober Luc, PHD, PharmD
role: STUDY_CHAIR
affiliation: Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile-Roux (AP-HP)
name: Bouillanne Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouillanne O, Neveux N, Nicolis I, Curis E, Cynober L, Aussel C. Long-lasting improved amino acid bioavailability associated with protein pulse feeding in hospitalized elderly patients: a randomized controlled trial. Nutrition. 2014 May;30(5):544-50. doi: 10.1016/j.nut.2013.10.006. Epub 2013 Oct 14.
citation: Bouillanne O, Curis E, Hamon-Vilcot B, Nicolis I, Chretien P, Schauer N, Vincent JP, Cynober L, Aussel C. Impact of protein pulse feeding on lean mass in malnourished and at-risk hospitalized elderly patients: a randomized controlled trial. Clin Nutr. 2013 Apr;32(2):186-92. doi: 10.1016/j.clnu.2012.08.015. Epub 2012 Aug 30.