Micronutrient and Malnourished Elderly | NCT02396121

Studies
Micronutrient and Malnourished Elderly

NCT02396121

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Mar 24, 2015Estimated

Enrollment

67Actual

Phase

Not Applicable

Conditions

Malnourished Elderly

Interventions

Oral nutritional supplement : Renutryl® Booster

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Feb 4, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional	Experimental	Administration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days.	Dietary Supplement: Oral nutritional supplement : Renutryl® Booster

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral nutritional supplement : Renutryl® Booster	Dietary Supplement		Interventional

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Nutritional status	Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)	28 days
Body composition	Impedance measurement

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided