Parkinson's Disease Clinical Trial
— SUPRESSIOfficial title:
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.
Status | Recruiting |
Enrollment | 184 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Spain | Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves | Granada | |
Spain | Department of Biochemistry and Molecular Biology II. University of Granada | Granada | |
Spain | Neurological Unit, Complejo Asistencial de León | León |
Lead Sponsor | Collaborator |
---|---|
Vegenat, S.A. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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