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

NCT ID: NCT00135590

Last Updated: 2007-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-10-31

Brief Summary

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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

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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

Conditions

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Protein-Energy Malnutrition

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Protein pulse-feeding

Group Type EXPERIMENTAL

Protein pulse-feeding

Intervention Type DIETARY_SUPPLEMENT

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

2

Spread diet

Group Type ACTIVE_COMPARATOR

Spread diet

Intervention Type DIETARY_SUPPLEMENT

Dietary protein was spread over the four meals.

Interventions

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Protein pulse-feeding

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

Intervention Type DIETARY_SUPPLEMENT

Spread diet

Dietary protein was spread over the four meals.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

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Aussel Christian, PHD, PharmD

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile Roux (AP-HP)

Cynober Luc, PHD, PharmD

Role: STUDY_CHAIR

Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Hôtel-Dieu (AP-HP)

Bouillanne Olivier, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux de Paris:Laboratoire de Biologie de la Nutrition EA 2498 and Hôpital Emile-Roux (AP-HP)

Locations

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Hôpital Emile-Roux (AP-HP)

Limeil-Brévannes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24355438 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22992307 (View on PubMed)

Other Identifiers

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AOR03003

Identifier Type: -

Identifier Source: secondary_id

PO30418

Identifier Type: -

Identifier Source: org_study_id