NCT02117609

Brief Summary

The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

3.1 years

First QC Date

April 16, 2014

Last Update Submit

October 6, 2015

Conditions

Malnutrition

Keywords

ElderlyNursing homeFunctional impairmentHigh-protein oral supplement

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in 4-meter walking speed

    After 3 months and 6 months

Secondary Outcomes (8)

  • Change from baseline in grip strength

    After 3 months and 6 months

  • Change from baseline in ADL (Activities Daily Living) score

    After 3 months and 6 months

  • Change from baseline in Geriatric Depression Scale

    After 3 months and 6 months

  • Change from baseline in quality of life (QOL-AD)

    After 3 months and 6 months

  • Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)

    During the 3 months and/or 6 months of consumption

  • +3 more secondary outcomes

Study Arms (2)

New DELICAL formula

EXPERIMENTAL

New high-protein oral nutrient supplement

Dietary Supplement: New DELICAL formula

Standard DELICAL formula

ACTIVE COMPARATOR

Standard isoenergetic isoprotein formula

Dietary Supplement: Standard DELICAL formula

Interventions

New DELICAL formulaDIETARY_SUPPLEMENT

3 months with the option of continuing until 6 months.

New DELICAL formula
Standard DELICAL formulaDIETARY_SUPPLEMENT

3 months with the option of continuing until 6 months.

Standard DELICAL formula

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman aged more than 60 years old
  • Living in a nursing home for at least 2 months
  • Malnourished or at risk of malnutrition (MNA\<23.5 or BMI\<24 or albumin\<35 g/l or weight loss of more than 5 kg in the last 6 months)
  • Without dementia or with moderate dementia (MMSE \> or =10/30)
  • Able to walk without human assistance (technical assistance allowed)
  • No vitamin D supplementation
  • Able to follow the study procedures and agreed to consume oral supplement

You may not qualify if:

  • Severe dementia (MMSE \< 10/30)
  • Enteral nutrition
  • Severe renal or hepatic impairment
  • Cancer with chemotherapy
  • Uncontrolled diabetes
  • Lactose intolerance
  • Cow's milk protein allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing homes - Région Midi-Pyrénées

Toulouse, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Yves Rolland, Pr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

  • Cécile Bonhomme, PhD

    Lactalis Nutrition Santé

    STUDY DIRECTOR

  • David Seguy, Dr

    U995, Université Lille Nord France

    STUDY CHAIR

  • Charlotte Baudry, PhD

    Lactalis Recherche et Développement

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 1, 2012

Primary Completion

June 1, 2015

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

FR(1)