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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UNKNOWN
NA
184 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Experimental Group
In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
Supressi. T-Diet plus Range
Supressi is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patients with neurodegenerative diseases and related malnutrition.
Experimental group patients will receive, 2 packs per day (Tetra brik aseptic)of 200 ml for 6 months.
Control Group
In addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product
High Protein. T-Diet plus Range
T-Diet plus High Protein is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patient with related malnutrition and with increased protein requirements.
Interventions
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Supressi. T-Diet plus Range
Supressi is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patients with neurodegenerative diseases and related malnutrition.
Experimental group patients will receive, 2 packs per day (Tetra brik aseptic)of 200 ml for 6 months.
High Protein. T-Diet plus Range
T-Diet plus High Protein is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patient with related malnutrition and with increased protein requirements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with or at malnutrition risk (Mini Nutritional Assessment screening positive)
Exclusion Criteria
* Patients with Diabetes mellitus poorly controlled (Glycemia \> 200 mg/dl)
* Patients with decompensated hypertension.
* Patients with pharmacological treatment or consuming supplements containing specific supplementation of experimental product (omega 3 and/or vitamins supplements).
* Post-stroke vascular dementias.
70 Years
ALL
No
Sponsors
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Vegenat, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Antonio J Pérez de la Cruz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Ángel Gil Hernández, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Biochemistry and Molecular Biology II. University of Granada
Adrián Arés Luque, MD
Role: PRINCIPAL_INVESTIGATOR
Neurological Unit, Complejo Asistencial de León
Locations
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Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Granada, Granada, Spain
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Granada, Spain
Neurological Unit, Complejo Asistencial de León
León, León, Spain
Countries
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Central Contacts
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Antonio J Pérez de la Cruz, MD PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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SUPRESSI2010-PROYECTO CDTI
Identifier Type: OTHER
Identifier Source: secondary_id
VEGENAT-SUPR
Identifier Type: -
Identifier Source: org_study_id
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