Micronutrient and Malnourished Elderly

Not Applicable

Completed

• Conditions: Malnourished Elderly

• Registration Number: NCT02396121
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Study First Posted: 2015-03-24
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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