Severe Insufficient Nutrition Clinical Trial
Official title:
Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care