NCT00135590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 22, 2007

Status Verified

November 1, 2004

First QC Date

August 24, 2005

Last Update Submit

November 20, 2007

Conditions

Protein-Energy Malnutrition

Keywords

Protein pulse-feedingNutritional supplementationProtein-energy malnutritionElderly subjectsBody composition

Outcome Measures

Primary Outcomes (1)

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

    42 days

Secondary Outcomes (6)

  • Immune functions

    42 days

  • Hand-grip strength

    42 days

  • Biological nutritional parameters

    42 days

  • Mortality and morbidity (infections and bedsores)

    42 days

  • Activity of Daily Living (ADL)

    42 days

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Protein pulse-feeding

Dietary Supplement: Protein pulse-feeding

2

ACTIVE COMPARATOR

Spread diet

Dietary Supplement: Spread diet

Interventions

Protein pulse-feedingDIETARY_SUPPLEMENT

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

1
Spread dietDIETARY_SUPPLEMENT

Dietary protein was spread over the four meals.

2

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Must be malnourished
  • Hospitalization into a geriatric rehabilitation care unit
  • Age \> 70 years
  • C-reactive protein (CRP) \< 50 mg/l

You may not qualify if:

  • Enteral or parenteral nutrition
  • Renal, cardiac or digestive insufficiency
  • Diabetes
  • Pacemaker
  • Mini-Mental State (MMS) \< 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Emile-Roux (AP-HP)

Limeil-Brévannes, 94456, France

Location

Related Publications (2)

  • 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.

    PMID: 24355438DERIVED

  • 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.

    PMID: 22992307DERIVED

MeSH Terms

Conditions

Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Protein DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Aussel Christian, PHD, PharmD

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

    STUDY DIRECTOR

  • Cynober Luc, PHD, PharmD

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

    STUDY CHAIR

  • Bouillanne Olivier, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

November 1, 2004

Study Completion

October 1, 2007

Last Updated

November 22, 2007

Record last verified: 2004-11

Locations

FR(1)