Clinical Evaluation of a Normoproteic Diet (STDUGR)
|ClinicalTrials.gov Identifier: NCT01303289|
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
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).
|Condition or disease||Intervention/treatment||Phase|
|Severe Insufficient Nutrition||Dietary Supplement: T-Diet plus Standard Dietary Supplement: Jevity||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||December 2007|
Experimental: Group 1
The group 1 will receive the experimental product T-Diet plus Standard for 3 months.
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.
Other Name: TDP STD
Active Comparator: Group 2
The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months.
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.
Other Name: JEV ABBT
- Nutritional status evaluation [ Time Frame: 6 months ]Clinical evaluation of a comercial product: T-Diet Plus (normoproteic and specific diet), when is used for total enteral nutrition in geriatric people.
- Specific parameters measure [ Time Frame: 6 months ]
- Confirm gastrointestinal and metabolic tolerance of the product.
- Consider the influence of the diet received on quality of life related to health.
- Study the changes in the nutritional status of elderly patients
- Assess changes in the lipid profile of patients
- Compare the evolution in blood levels of metabolic syndrome indicator parameters and other related to cardiovascular morbidity.
- Assess changes in the antioxidant defense system.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303289
|Department of Biochemistry and Molecular Biology II. University of Granada|
|Granada, Spain, 18100|
|Principal Investigator:||Ángel Gil, PhD||Departament of Biochemistry and Molecular Biology II. University of Granada|