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Clinical Evaluation of a Normoproteic Diet (STDUGR)

This study has been completed.
Sponsor:
Information provided by:
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01303289
First received: February 17, 2011
Last updated: February 22, 2011
Last verified: February 2011
History of Changes

February 17, 2011
February 22, 2011
February 2006
January 2007   (final data collection date for primary outcome measure)
Nutritional status evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical evaluation of a comercial product: T-Diet Plus (normoproteic and specific diet), when is used for total enteral nutrition in geriatric people.
Same as current
Complete list of historical versions of study NCT01303289 on ClinicalTrials.gov Archive Site
Specific parameters measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  1. Confirm gastrointestinal and metabolic tolerance of the product.
  2. Consider the influence of the diet received on quality of life related to health.
  3. Study the changes in the nutritional status of elderly patients
  4. Assess changes in the lipid profile of patients
  5. Compare the evolution in blood levels of metabolic syndrome indicator parameters and other related to cardiovascular morbidity.
  6. Assess changes in the antioxidant defense system.
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of a Normoproteic Diet
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Severe Insufficient Nutrition
  • 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
  • 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
  • Experimental: Group 1
    The group 1 will receive the experimental product T-Diet plus Standard for 3 months.
    Intervention: Dietary Supplement: T-Diet plus Standard
  • Active Comparator: Group 2
    The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months.
    Intervention: Dietary Supplement: Jevity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 65 years old, of both sex, receiving total enteral nutrition by tube.
  • Admitted to medically supervised institutions (homes, health centers).
  • Requirement for total enteral nutrition standard, at least 3 months.
  • Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves).

Exclusion Criteria:

  • Patients who receive drugs with lipid composition.
  • Unstable clinical situation.
  • Patients with terminal illness.
  • Refusal or physical or mental inability to cooperate in the study.
  • Participating in another study.
  • Other causes: social causes, humanitarian, non-cooperation, etc..
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01303289
VEGENAT-TDP STD UGR, TDP STANDARD 2006
No
África Jiménez Jiménez, VEGENAT, S.A.
Vegenat, S.A.
Not Provided
Principal Investigator: Ángel Gil, PhD Departament of Biochemistry and Molecular Biology II. University of Granada
Vegenat, S.A.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP