Alzheimer's Disease | Evaluation of a Diet in Patients With Senile Dementia
Alzheimer's Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Supressi. T-Diet plus RangeSupressi 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 Supplement:High Protein. T-Diet plus RangeT-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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Experimental GroupIn addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
Control GroupIn addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product
Start Date: October 2010
Completed Date: December 2012
Primary Outcome: Nutritional and cognitive status in elderly people
Secondary Outcome: Biochemical parameters measure
Study sponsors, principal investigator, and references
Principal Investigator: Antonio J Pérez de la Cruz, MD PhD
Lead Sponsor: Vegenat, S.A.