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Sponsored by: |
University Hospital, Rouen |
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Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00877578 |
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.
The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.
Condition | Intervention |
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Malnutrition |
Dietary Supplement: Nutri-Energie ®, Aliscience society Dietary Supplement: Clinutren 1.5 ®, Nestlé Clinical Nutrition |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients |
Estimated Enrollment: | 80 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Nutri-Energie ®, a cake of high caloric density and palatability, twice a day for 4 weeks, in addition to an enriched diet.
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Dietary Supplement: Nutri-Energie ®, Aliscience society
Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.
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2: Active Comparator
Clinutren 1.5 ® standard isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet.
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Dietary Supplement: 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
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Ageing of the population and loss of autonomy expose to major consequences in terms of treatment charges and need for hospitalisation. Malnutrition has a key prognostic value, that worsen the prognosis of the primary disease; the length of hospital stay and the incidence of complications are related to nutritional status (Correia 2003, Pichard 2004, Schneider 2004). Several large scale studies at Rouen University Hospital, in 1998 and 2001, have revealed on more than 1000 patients (mid age 71 years) that malnutrition prevalence ranged of 35 to 38%, one third of which is severe (Jusserand 2000, Delaire 2002). Malnutrition increases the risk of complications (Naber 1997, Correia 2003), including muscle mass depletion, decrease of immune function and delayed wound healing. The main consequence of malnutrition is increased infectious morbidity and post operative mortality for the weakest patients.
Increased length of hospital stay and rehabilitation duration also results in increased medicals and social burden, in particular in the elderly patients.
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.
Ages Eligible for Study: | 70 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
Exclusion Criteria:
Contact: Pierre DECHELOTTE, PR | +33232888122 | Pierre.Dechelotte@chu-rouen.fr |
France | |
UHRouen | |
ROUEN, France, 76031 |
Principal Investigator: | Pierre DECHELOTTE, PR | University Hospital, Rouen |
Responsible Party: | University Hospital, Rouen ( Francois TEILLARD - Reserach and Innovation Director ) |
Study ID Numbers: | 2007/023/HP |
Study First Received: | April 7, 2009 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00877578 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
elderly patient malnutrition new nutritional support micronutrients elderly patient malnutrition |
Malnutrition Nutrition Disorders Trace Elements Micronutrients |
Malnutrition Nutrition Disorders |