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

NCT00877578 | Completed

• 1 other identifier: 2007/023/HP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malnutrition

Keywords

elderly patient; malnutrition; new nutritional support; micronutrients; elderly patient malnutrition

Outcome Measures

Primary Outcomes (1)

• outcome of fat-free mass measured by multiple frequence bio-impedance analysis

  28 days

Secondary Outcomes (1)

• safety of oral supplementation

  28 days

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

Nutri-Energie ®, Aliscience society DIETARY_SUPPLEMENT

Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.

1

Clinutren 1.5 ®, Nestlé Clinical Nutrition DIETARY_SUPPLEMENT

Clinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet

2

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female participants
• Moderately malnourished defined by whether:
• \< BMI \< 21
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (2)

Centre Hospitalier de Dieppe

Dieppe, 76200, France

Location

UHRouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Pierre DECHELOTTE, PR

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

FR (2)