Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients

Malnutrition Clinical Trial

— Nutri-PA  

Official title:

Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877578
• Other study ID #: 2007/023/HP
• Status: Completed
• Phase: N/A
• First received: April 7, 2009
• Last updated: October 15, 2013
• Start date: April 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria:

• Both male and female participants

• 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:

• Age < 70 years old or > 90 years old

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier de Dieppe	Dieppe
France	UHRouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	outcome of fat-free mass measured by multiple frequence bio-impedance analysis		28 days	No
Secondary	safety of oral supplementation		28 days	Yes