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

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00135590

Purpose

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.

Condition	Intervention
Protein-Energy Malnutrition	Dietary Supplement: Protein pulse-feeding Dietary Supplement: Spread diet

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	68
Study Start Date:	November 2004
Study Completion Date:	October 2007

Arms	Assigned Interventions
1: Experimental Protein pulse-feeding	Dietary Supplement: Protein pulse-feeding Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
2: Active Comparator Spread diet	Dietary Supplement: Spread diet Dietary protein was spread over the four meals.

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

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135590

Locations

France
Hôpital Emile-Roux (AP-HP)
Limeil-Brevannes, France, 94456

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Study Director:	Aussel Christian, PHD, PharmD	Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile Roux (AP-HP)
Study Chair:	Cynober Luc, PHD, PharmD	Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Hôtel-Dieu (AP-HP)
Principal Investigator:	Bouillanne Olivier, MD	Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile-Roux (AP-HP)

More Information

No publications provided

Study ID Numbers:	PO30418, AOR03003
Study First Received:	August 24, 2005
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00135590 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Study placed in the following topic categories:

Protein Deficiency
Malnutrition
Nutrition Disorders
Protein-Energy Malnutrition
Deficiency Diseases

Additional relevant MeSH terms:

Protein Deficiency
Malnutrition
Nutrition Disorders
Protein-Energy Malnutrition
Deficiency Diseases

ClinicalTrials.gov processed this record on July 06, 2009