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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
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Parkinson's Disease
Senile Dementia
 Dietary Supplement: Supressi. T-Diet plus Range
Dietary Supplement: High Protein. T-Diet plus Range

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of an Specific Diet for People With Dementia Disease

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 184
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192529

Contacts
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

Locations
Spain
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     antonioj.perez.sspa@juntadeandalulcia.es    
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     agil@ugr.es    
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     adrianares@telefonica.net    
Principal Investigator: Adrián Arés Luque, MD            
Sponsors and Collaborators
Vegenat, S.A.
Investigators
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
  More Information

No publications provided

Responsible Party: Vegenat, S.A.
ClinicalTrials.gov Identifier: NCT01192529     History of Changes
Other Study ID Numbers: VEGENAT-SUPR, SUPRESSI2010-PROYECTO CDTI
Study First Received: August 30, 2010
Last Updated: June 21, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Vegenat, S.A.:
Senile
Dementia
Neurodegenerative
Supressi
Specific diet
 Cognitive Status
Memory
Malnutrition
Parkinson
Alzheimer

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Parkinson Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
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