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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
  Purpose

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 Intervention
Severe Insufficient Nutrition
 Dietary Supplement: T-Diet plus Standard
Dietary Supplement: Jevity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vegenat, S.A.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: February 2006
Study Completion Date: December 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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..
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303289

Locations
Spain
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Spain, 18100
Sponsors and Collaborators
Vegenat, S.A.
Investigators
Principal Investigator: Ángel Gil, PhD Departament of Biochemistry and Molecular Biology II. University of Granada
  More Information

No publications provided

Responsible Party: África Jiménez Jiménez, VEGENAT, S.A.
ClinicalTrials.gov Identifier: NCT01303289     History of Changes
Other Study ID Numbers: VEGENAT-TDP STD UGR, TDP STANDARD 2006
Study First Received: February 17, 2011
Last Updated: February 22, 2011
Health Authority: Spain: Ministry of Health and Consumption
Spain: Comité Ético de Investigación Clínica

Keywords provided by Vegenat, S.A.:
Total Enteral Nutrition
Severe insufficient nutrition
T-Diet plus Standard
Lipidic profile
Quality of life

Additional relevant MeSH terms:
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Appetite Depressants
 Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013