Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients
NCT ID: NCT00877578
Last Updated: 2013-10-16
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
NA
40 participants
INTERVENTIONAL
2009-04-30
2011-07-31
Brief Summary
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The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.
Detailed Description
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Recent studies have shown that usual hospital food intake was insufficient to cover patient's needs (Hébuterne 2001, Dupertuis 2003, Petit 2004) and that systematic nutritional screening was mandatory in hospitalised patients, using validated criteria and scales (e.g. NutriSteps®, MNA®).
The strategy for nutritional support includes as a first step enriched diets and the use of oral supplements, then enteral nutrition or even parenteral nutrition in the most severe cases (HAS guidelines 2007). The efficacy of oral supplementation has been proven (Stratton 2007). Yet, their composition still need to be optimised to better match specific nutritional needs and to ameliorate palatability and favour compliance.
The provision of specifics nutrients with anabolic, anti-oxidants or anti-inflammatory effects can optimise oral nutritional supplements, to achieve a true pharmaco-nutritional therapy. Accordingly, leucine enrichment has inhibitory effects on proteasome-mediated muscular proteolysis in aged rats (Combaret 2005). Trace elements deficiency (zinc, selenium, chromium, iron) is common in the elderly patients and increase the risk of infectious or wound complications (HAS 2007), and the level of trace elements provision in standard supplements may be insufficient to compensate this deficiency. Finally, omega-3 fatty acids enrichment enables to limit the inflammatory response and hypercatabolism (Delarue 2005).
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Nutri-Energie ®, a cake of high caloric density and palatability, twice a day for 4 weeks, in addition to an enriched diet.
Nutri-Energie ®, Aliscience society
Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.
2
Clinutren 1.5 ® standard isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet.
Clinutren 1.5 ®, Nestlé Clinical Nutrition
Clinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet
Interventions
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Nutri-Energie ®, Aliscience society
Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.
Clinutren 1.5 ®, Nestlé Clinical Nutrition
Clinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet
Eligibility Criteria
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Inclusion Criteria
* Moderately malnourished defined by whether:
18 \< BMI \< 21
5 to 10% body weight loss in the last past 6 months.
Buzby index between 83.5 and 97.5 (calculated with weight loss and albumin)
* With or without any factors increasing malnutrition (insufficient caloric intakes, long term treatment)
* Justifying hospitalisation in rehabilitation unit
Exclusion Criteria
* Surgical affection involving a surgery in the next 10 days
* Contraindicated oral intakes due to digestive injury
* Total parenteral nutrition
* Ulcer or infection existing
* Malignant hemopathy
* Hepatic insufficiency (TP \< 30%)
* Swallowing difficulties limiting solid oral intakes
* Kidney failure (renal dialysis)
* Expected survival \> 3 months
* Impossibility to give an informed consent
60 Years
95 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Pierre DECHELOTTE, PR
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Centre Hospitalier de Dieppe
Dieppe, , France
UHRouen
Rouen, , France
Countries
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Other Identifiers
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2007/023/HP
Identifier Type: -
Identifier Source: org_study_id