Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2006-02-28
2007-12-31
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group 1
The group 1 will receive the experimental product T-Diet plus Standard for 3 months.
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.
Group 2
The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months.
Jevity
JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.
Interventions
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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.
Jevity
JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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..
65 Years
ALL
No
Sponsors
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Vegenat, S.A.
INDUSTRY
Responsible Party
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VEGENAT, S.A.
Principal Investigators
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Ángel Gil, PhD
Role: PRINCIPAL_INVESTIGATOR
Departament of Biochemistry and Molecular Biology II. University of Granada
Locations
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Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Granada, Spain
Countries
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Other Identifiers
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TDP STANDARD 2006
Identifier Type: OTHER
Identifier Source: secondary_id
VEGENAT-TDP STD UGR
Identifier Type: -
Identifier Source: org_study_id
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