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Micronutrient and Malnourished Elderly (Reboot)

Primary Purpose

Malnourished Elderly

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral nutritional supplement : Renutryl® Booster
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnourished Elderly

Eligibility Criteria

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

Inclusion Criteria:

  • Age : above or equal to 70 years

AND :

  • Weight loss above or equal to 5% in one month
  • OR weight loss above or equal to 10% in 6 months
  • OR BMI between 18 and 21
  • OR albuminaemia between 30 and 35 g/L
  • OR MNA-SF less or equal to 7

Exclusion Criteria:

  • Severe malnutrition
  • Contraindication to oral nutrition
  • Severe pathologies
  • Inflammatory syndrome (CRP > 30 mg/L)
  • Severe dementia (Mini Mental Score < 10)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Interventional

    Arm Description

    Administration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days.

    Outcomes

    Primary Outcome Measures

    Change from baseline in micronutrients status after 28 days
    Biological analyses of micronutrient

    Secondary Outcome Measures

    Nutritional status
    Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)
    Body composition
    Impedance measurement
    Compliance
    Compliance measured by bottle weight before and after consumption
    Autonomy
    "Get up and go" test

    Full Information

    First Posted
    February 4, 2015
    Last Updated
    March 17, 2015
    Sponsor
    Société des Produits Nestlé (SPN)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02396121
    Brief Title
    Micronutrient and Malnourished Elderly
    Acronym
    Reboot
    Official Title
    Évaluation de l'évolution du Statut Nutritionnel en Micronutriment Chez Les Patients âgés dénutris bénéficiant d'Une complémentation Nutritionnelle Orale
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Société des Produits Nestlé (SPN)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnourished Elderly

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Interventional
    Arm Type
    Experimental
    Arm Description
    Administration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Oral nutritional supplement : Renutryl® Booster
    Primary Outcome Measure Information:
    Title
    Change from baseline in micronutrients status after 28 days
    Description
    Biological analyses of micronutrient
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Nutritional status
    Description
    Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)
    Time Frame
    28 days
    Title
    Body composition
    Description
    Impedance measurement
    Time Frame
    28 days
    Title
    Compliance
    Description
    Compliance measured by bottle weight before and after consumption
    Time Frame
    28 days
    Title
    Autonomy
    Description
    "Get up and go" test
    Time Frame
    28 fays

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age : above or equal to 70 years AND : Weight loss above or equal to 5% in one month OR weight loss above or equal to 10% in 6 months OR BMI between 18 and 21 OR albuminaemia between 30 and 35 g/L OR MNA-SF less or equal to 7 Exclusion Criteria: Severe malnutrition Contraindication to oral nutrition Severe pathologies Inflammatory syndrome (CRP > 30 mg/L) Severe dementia (Mini Mental Score < 10)

    12. IPD Sharing Statement

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    Micronutrient and Malnourished Elderly

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