Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
NCT ID: NCT02117609
Last Updated: 2015-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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New DELICAL formula
New high-protein oral nutrient supplement
New DELICAL formula
3 months with the option of continuing until 6 months.
Standard DELICAL formula
Standard isoenergetic isoprotein formula
Standard DELICAL formula
3 months with the option of continuing until 6 months.
Interventions
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New DELICAL formula
3 months with the option of continuing until 6 months.
Standard DELICAL formula
3 months with the option of continuing until 6 months.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Enteral nutrition
* Severe renal or hepatic impairment
* Cancer with chemotherapy
* Uncontrolled diabetes
* Lactose intolerance
* Cow's milk protein allergy
60 Years
ALL
Yes
Sponsors
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University Hospital, Toulouse
OTHER
University of Lille Nord de France
OTHER
National Research Agency, France
OTHER
Lactalis
INDUSTRY
Responsible Party
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Principal Investigators
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Yves Rolland, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Cécile Bonhomme, PhD
Role: STUDY_DIRECTOR
Lactalis Nutrition Santé
David Seguy, Dr
Role: STUDY_CHAIR
U995, Université Lille Nord France
Charlotte Baudry, PhD
Role: STUDY_CHAIR
Lactalis Recherche et Développement
Locations
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Nursing homes - Région Midi-Pyrénées
Toulouse, , France
Countries
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Other Identifiers
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ANR ALIA2010-01306 Presage
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LRD-2011-PRESAGE
Identifier Type: -
Identifier Source: org_study_id
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