Back to resultsEvaluation of a Diet in Patients With Senile Dementia (SUPRESSI)
Primary Purpose
Alzheimer's Disease, Parkinson's Disease, Senile Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supressi. T-Diet plus Range
High Protein. T-Diet plus Range
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Senile, Dementia, Neurodegenerative, Supressi, Specific diet, Cognitive Status, Memory, Malnutrition, Parkinson, Alzheimer
Eligibility 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.
Sites / Locations
- Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las NievesRecruiting
- Department of Biochemistry and Molecular Biology II. University of GranadaRecruiting
- Neurological Unit, Complejo Asistencial de León
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
In addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product
Outcomes
Primary Outcome Measures
Nutritional and cognitive status in elderly people
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01192529
Brief Title
Evaluation of a Diet in Patients With Senile Dementia
Acronym
SUPRESSI
Official Title
Clinical Evaluation of an Specific Diet for People With Dementia Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vegenat, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Parkinson's Disease, Senile Dementia
Keywords
Senile, Dementia, Neurodegenerative, Supressi, Specific diet, Cognitive Status, Memory, Malnutrition, Parkinson, Alzheimer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
In addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product
Intervention Type
Dietary Supplement
Intervention Name(s)
Supressi. T-Diet plus Range
Other Intervention Name(s)
VEG001
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High Protein. T-Diet plus Range
Other Intervention Name(s)
VEG002
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional and cognitive status in elderly people
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Biochemical parameters measure
Description
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.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ángel Gil Hernández, PhD
Phone
+34 695 466 922
Email
agil@ugr.es
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio J Pérez de la Cruz, MD PhD
Phone
+34 639 236 825
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio J Pérez de la Cruz, MD PhD
Organizational Affiliation
Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ángel Gil Hernández, PhD
Organizational Affiliation
Department of Biochemistry and Molecular Biology II. University of Granada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrián Arés Luque, MD
Organizational Affiliation
Neurological Unit, Complejo Asistencial de León
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio J Pérez de la Cruz, MD, PhD
Phone
+ 34 639 236 825
Email
antonioj.perez.sspa@juntadeandalulcia.es
First Name & Middle Initial & Last Name & Degree
Antonio J Pérez de la Cruz, MD, PhD
Facility Name
Department of Biochemistry and Molecular Biology II. University of Granada
City
Granada
ZIP/Postal Code
18100
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ángel Gil Hernández, PhD
Phone
+34 695 466 922
Email
agil@ugr.es
First Name & Middle Initial & Last Name & Degree
Ángel Gil Hernández, PhD
Facility Name
Neurological Unit, Complejo Asistencial de León
City
León
ZIP/Postal Code
24071
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrián Arés Luque, MD
Phone
+34 609 022 840
Email
adrianares@telefonica.net
First Name & Middle Initial & Last Name & Degree
Adrián Arés Luque, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Diet in Patients With Senile Dementia
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