Evaluation of a Diet in Patients With Senile Dementia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of an Specific Diet for People With Dementia Disease

Conditions
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Alzheimer's Disease, Parkinson's Disease, Senile Dementia

Intervention / Treatment
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* Dietary Supplement: Supressi. T-Diet plus Range
* Dietary Supplement: High Protein. T-Diet plus Range


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* 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.<br>* Other names: VEG001;|
| Active Comparator: Control Group<br>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<br>* 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.<br>* Other names: VEG002;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Senile, Dementia, Neurodegenerative, Supressi, Specific diet, Cognitive Status, Memory, Malnutrition, Parkinson, Alzheimer