Micronutrient and Malnourished Elderly

NCT ID: NCT02396121

Last Updated: 2015-03-24

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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

Detailed Description

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Conditions

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Malnourished Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

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

Group Type EXPERIMENTAL

Oral nutritional supplement : Renutryl® Booster

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oral nutritional supplement : Renutryl® Booster

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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12.01.FR.NHS

Identifier Type: -

Identifier Source: org_study_id

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