NCT01303289

Clinical Evaluation of a Normoproteic Diet

Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Vegenat, S.A. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people. For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).

Detailed description

The project includes: * Product tolerance study: gastrointestinal and metabolic complications related to the product administration. * The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry). * The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.

Conditions

• Severe Insufficient Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	T-Diet plus Standard	T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
DIETARY_SUPPLEMENT	Jevity	JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-01-01
• Completion: 2007-12-01
• First posted: 2011-02-24
• Last updated: 2011-02-24

Locations

1 site across 1 country: Spain