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

Primary Purpose

Protein-Energy Malnutrition

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Protein pulse-feeding
Spread diet
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein-Energy Malnutrition focused on measuring Protein pulse-feeding, Nutritional supplementation, Protein-energy malnutrition, Elderly subjects, Body composition

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Emile-Roux (AP-HP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Protein pulse-feeding

Spread diet

Outcomes

Primary Outcome Measures

Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2005
Last Updated
November 20, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00135590
Brief Title
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Acronym
PRO-PULSé
Official Title
Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-Energy Malnutrition
Keywords
Protein pulse-feeding, Nutritional supplementation, Protein-energy malnutrition, Elderly subjects, Body composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Protein pulse-feeding
Arm Title
2
Arm Type
Active Comparator
Arm Description
Spread diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein pulse-feeding
Intervention Description
Dietary protein (80% of daily intake) was consumed in one meal (12.00h)
Intervention Type
Dietary Supplement
Intervention Name(s)
Spread diet
Intervention Description
Dietary protein was spread over the four meals.
Primary Outcome Measure Information:
Title
Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Immune functions
Time Frame
42 days
Title
Hand-grip strength
Time Frame
42 days
Title
Biological nutritional parameters
Time Frame
42 days
Title
Mortality and morbidity (infections and bedsores)
Time Frame
42 days
Title
Activity of Daily Living (ADL)
Time Frame
42 days
Title
Plasmatic amino acid levels
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aussel Christian, PHD, PharmD
Organizational Affiliation
Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile Roux (AP-HP)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cynober Luc, PHD, PharmD
Organizational Affiliation
Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Hôtel-Dieu (AP-HP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bouillanne Olivier, MD
Organizational Affiliation
Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile-Roux (AP-HP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Emile-Roux (AP-HP)
City
Limeil-Brevannes
ZIP/Postal Code
94456
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24355438
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.
Results Reference
derived
PubMed Identifier
22992307
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.
Results Reference
derived

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

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