Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nutri-Energie ®, Aliscience society; Clinutren 1.5 ®, Nestlé Clinical Nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.; Clinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: elderly patient; malnutrition; new nutritional support; micronutrients; elderly patient malnutrition