Evaluation of a Diet in Patients With Senile Dementia (SUPRESSI)
|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.|
|ClinicalTrials.gov Identifier: NCT01192529|
Recruitment Status : Unknown
Verified February 2011 by Vegenat, S.A..
Recruitment status was: Recruiting
First Posted : September 1, 2010
Last Update Posted : June 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Parkinson's Disease Senile Dementia||Dietary Supplement: Supressi. T-Diet plus Range Dietary Supplement: High Protein. T-Diet plus Range||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Evaluation of an Specific Diet for People With Dementia Disease|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||December 2012|
U.S. FDA Resources
Experimental: Experimental Group
In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
Dietary 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.
Other Name: VEG001
Active Comparator: 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
Dietary Supplement: 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 Name: VEG002
- Nutritional and cognitive status in elderly people [ Time Frame: 1 year ]The evaluation include: Nutritional evaluation, Improvement of Anthropometric and Biochemical parameters evaluation in relation to patient malnutrition, Patient's cognitive status evaluation (Folstein's MMSE and GDS scale), Functional and psychopathological aspects evaluation (blessed Scale), Global Impresion of Change Evaluation(CIBIC plus Scale), Quality of life evaluation (Short Form 36 questionaire), Memory Evaluation (Rey Auditory Learning Test), Appearance of gastrointestinal events evaluation, Diet and Intake acceptance evaluation.
- Biochemical parameters measure [ Time Frame: 8 months ]Fatty acid profile of plasma and erythrocytes, plasma levels of some proinflammatory cytokines and b-amyloid, genotyped, oxidative stress determination, total proteins determination, total lymphocytes, albumin, pre-albumin, transferrine, Reactive C protein (RCP), homocystein, total cholesterol, plasma level of glucose, Homeostasis Model Assessment and Renal function.
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 ClinicalTrials.gov identifier (NCT number): NCT01192529
|Contact: Ángel Gil Hernández, PhD||+34 695 466 firstname.lastname@example.org|
|Contact: Antonio J Pérez de la Cruz, MD PhD||+34 639 236 825|
|Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves||Recruiting|
|Granada, Spain, 18014|
|Contact: Antonio J Pérez de la Cruz, MD, PhD + 34 639 236 825 email@example.com|
|Principal Investigator: Antonio J Pérez de la Cruz, MD, PhD|
|Department of Biochemistry and Molecular Biology II. University of Granada||Recruiting|
|Granada, Spain, 18100|
|Contact: Ángel Gil Hernández, PhD +34 695 466 922 firstname.lastname@example.org|
|Principal Investigator: Ángel Gil Hernández, PhD|
|Neurological Unit, Complejo Asistencial de León||Not yet recruiting|
|León, Spain, 24071|
|Contact: Adrián Arés Luque, MD +34 609 022 840 email@example.com|
|Principal Investigator: Adrián Arés Luque, MD|
|Principal Investigator:||Antonio J Pérez de la Cruz, MD PhD||Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves|
|Principal Investigator:||Ángel Gil Hernández, PhD||Department of Biochemistry and Molecular Biology II. University of Granada|
|Principal Investigator:||Adrián Arés Luque, MD||Neurological Unit, Complejo Asistencial de León|