NCT02396121

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
Last Updated

March 24, 2015

Status Verified

February 1, 2015

Enrollment Period

1.6 years

First QC Date

February 4, 2015

Last Update Submit

March 17, 2015

Conditions

Malnourished Elderly

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in micronutrients status after 28 days

    Biological analyses of micronutrient

    28 days

Secondary Outcomes (4)

  • Nutritional status

    28 days

  • Body composition

    28 days

  • Compliance

    28 days

  • Autonomy

    28 fays

Study Arms (1)

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

Oral nutritional supplement : Renutryl® BoosterDIETARY_SUPPLEMENT
Interventional

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe malnutrition
  • Contraindication to oral nutrition
  • Severe pathologies
  • Inflammatory syndrome (CRP \> 30 mg/L)
  • Severe dementia (Mini Mental Score \< 10)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

March 24, 2015

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-02