Micronutrient and Malnourished Elderly (Reboot)

March 17, 2015 updated by: Nestlé

Évaluation de l'évolution du Statut Nutritionnel en Micronutriment Chez Les Patients âgés dénutris bénéficiant d'Une complémentation Nutritionnelle Orale

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Administration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days.
Dietary supplement: Oral nutritional supplement : Renutryl® Booster

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in micronutrients status after 28 days
Time Frame: 28 days
Biological analyses of micronutrient
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 28 days
Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)
28 days
Body composition
Time Frame: 28 days
Impedance measurement
28 days
Compliance
Time Frame: 28 days
Compliance measured by bottle weight before and after consumption
28 days
Autonomy
Time Frame: 28 fays
"Get up and go" test
28 fays

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.01.FR.NHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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