Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients (Nutri-PA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00877578
First received: April 7, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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
Malnutrition
Dietary Supplement: Nutri-Energie ®, Aliscience society
Dietary Supplement: Clinutren 1.5 ®, Nestlé Clinical Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • outcome of fat-free mass measured by multiple frequence bio-impedance analysis [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of oral supplementation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nutri-Energie ®, a cake of high caloric density and palatability, twice a day for 4 weeks, in addition to an enriched diet.
Dietary Supplement: Nutri-Energie ®, Aliscience society
Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.
Active Comparator: 2
Clinutren 1.5 ® standard isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet.
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877578

Locations
France
Centre Hospitalier de Dieppe
Dieppe, France, 76200
UHRouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pierre DECHELOTTE, PR University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00877578     History of Changes
Other Study ID Numbers: 2007/023/HP
Study First Received: April 7, 2009
Last Updated: October 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
elderly patient
malnutrition
new nutritional support
micronutrients
elderly patient malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 19, 2014