COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Clinical Evaluation of a Normoproteic Diet (STDUGR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303289
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Information provided by:
Vegenat, S.A.

Brief 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).

Condition or disease Intervention/treatment Phase
Severe Insufficient Nutrition Dietary Supplement: T-Diet plus Standard Dietary Supplement: Jevity Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Specific parameters measure [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303289

Layout table for location information
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Spain, 18100
Sponsors and Collaborators
Vegenat, S.A.
Layout table for investigator information
Principal Investigator: Ángel Gil, PhD Departament of Biochemistry and Molecular Biology II. University of Granada
Layout table for additonal information
Responsible Party: África Jiménez Jiménez, VEGENAT, S.A. Identifier: NCT01303289    
Other Study ID Numbers: VEGENAT-TDP STD UGR
TDP STANDARD 2006 ( Other Identifier: VEGENAT, S.A. )
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011
Keywords provided by Vegenat, S.A.:
Total Enteral Nutrition
Severe insufficient nutrition
T-Diet plus Standard
Lipidic profile
Quality of life