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OpenTrials
Completed

NCT Number: NCT02396121

Micronutrient and Malnourished Elderly

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

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Key information

Conditions

Malnourished Elderly

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Oral nutritional supplement : Renutryl® Booster

Dietary Supplement

Primary outcomes

  1. Change from baseline in micronutrients status after 28 days

    Time frame: 28 days

    Biological analyses of micronutrient

Secondary outcomes

  1. Nutritional status

    Time frame: 28 days

    Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)

  2. Body composition

    Time frame: 28 days

    Impedance measurement

  3. Compliance

    Time frame: 28 days

    Compliance measured by bottle weight before and after consumption

  4. Autonomy

    Time frame: 28 fays

    "Get up and go" test

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Acronym: Reboot

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2015
Registry last updated
Mar 24, 2015

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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