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Completed

NCT Number: NCT00135590

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

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.

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Key information

Conditions

Protein-energy Malnutrition Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Emile-Roux (AP-HP)

Limeil-Brévannes, 94456, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein pulse-feeding

Dietary Supplement

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

Spread diet

Dietary Supplement

Dietary protein was spread over the four meals.

Primary outcomes

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

    Time frame: 42 days

Secondary outcomes

  1. Immune functions

    Time frame: 42 days

  2. Hand-grip strength

    Time frame: 42 days

  3. Biological nutritional parameters

    Time frame: 42 days

  4. Mortality and morbidity (infections and bedsores)

    Time frame: 42 days

  5. Activity of Daily Living (ADL)

    Time frame: 42 days

  6. Plasmatic amino acid levels

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PRO-PULSé

Important dates

Study start
2004
Study completion
2007
First posted
Aug 26, 2005
Registry last updated
Nov 22, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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