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Evaluation of a Diet in Patients With Senile Dementia (SUPRESSI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Vegenat, S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01192529
First received: August 30, 2010
Last updated: June 21, 2012
Last verified: February 2011
History of Changes

August 30, 2010
June 21, 2012
October 2010
September 2012   (final data collection date for primary outcome measure)
Nutritional and cognitive status in elderly people [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01192529 on ClinicalTrials.gov Archive Site
Biochemical parameters measure [ Time Frame: 8 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Evaluation of a Diet in Patients With Senile Dementia
Clinical Evaluation of an Specific Diet for People With Dementia Disease

The most common symptoms associated to senile dementia disease are confusion about schedules, hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in malnutrition problems or malnutrition high risk.

The purpose of this study is to assess if the daily intake of a specific nutritional supplement versus a non specific supplement one is related to malnutrition or malnutrition risk reduction and contributes to an improvement in cognitive and functional parameters in patients with senile dementia.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
  • Alzheimer's Disease
  • Parkinson's Disease
  • Senile Dementia
  • 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
  • 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
  • Experimental: Experimental Group
    In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
    Intervention: Dietary Supplement: Supressi. T-Diet plus Range
  • 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
    Intervention: Dietary Supplement: High Protein. T-Diet plus Range
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
184
December 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 70 years with neurologist or geriatrician dementia diagnosis (Alzheimer's disease, Parkinson's or mixed), with mild or moderate cognitive impairment degree (Between 24 and 14 MMSE).
  • Patients with or at malnutrition risk (Mini Nutritional Assessment screening positive)

Exclusion Criteria:

  • Patients with decompensated kidney failure, creatine and/or bilirubin greater than 2, uric acid higher than 8 mg/dl, and glomerular filtration under 60 ml/minute.
  • 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.
  • Do not achieve any inclusion criteria.
Both
70 Years and older
No
Contact: Ángel Gil Hernández, PhD +34 695 466 922 agil@ugr.es
Contact: Antonio J Pérez de la Cruz, MD PhD +34 639 236 825
Spain
 
NCT01192529
VEGENAT-SUPR, SUPRESSI2010-PROYECTO CDTI
No
Vegenat, S.A.
Vegenat, S.A.
Not Provided
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
Vegenat, S.A.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP