Alzheimer's Disease, Parkinson's Disease, Senile Dementia
Conditions
Keywords
Senile, Dementia, Neurodegenerative, Supressi, Specific diet, Cognitive Status, Memory, Malnutrition, Parkinson, Alzheimer
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.
Interventions
DIETARY_SUPPLEMENTSupressi. 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.
DIETARY_SUPPLEMENTHigh 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.
Sponsors
Vegenat, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional and cognitive status in elderly people | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical parameters measure | 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. |
Countries
Spain
Contacts
Primary ContactÁngel Gil Hernández, PhD
Backup ContactAntonio J Pérez de la Cruz, MD PhD
Outcome results
None listed