Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment

Study Overview
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Brief Summary
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The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease

Detailed Description
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The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances: A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI) A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level. A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1). In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4) Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it. Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment. Polyunsaturated fatty acids (PUFA) can help to improve the cognitive functions. Neuronal tissues, as the brain, retina and the neurone-covering membranes (myelin) include high levels of PUFA. (5) PUFA's act on the order transmission in the Nervous System. Population studies reported the beneficial effect of fish oil, with a high PUFA concentration, on the memory of patients suffering a mild cognitive impairment. (6) It can be also beneficial for Alzheimer's patients, as they are deficient in PUFA's. A diet rich in PUFA'S can improve the cognitive function on patients con cognitive impairment and Alzheimer's disease. (6-8) Epidemiological studies suggest that oils rich in short chain PUFA, should play a beneficial role stopping the initial progression of Alzheimer's disease. The previous data confirm the possibility of a beneficial effect of the product to study (a mixture of vegetable oils, rich in triglyceride and lecithins) due to the common characteristic of the product with those PUFA's already marketed.

Official Title
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Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.

Conditions
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Cognitive Impairments, Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: Lipidic Blend 1
* Dietary Supplement: Lipidic Blend 2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consents signed by patients and/or caretaker The patient has to fulfil dementia clinical criteria. Age between 55 and 85 years old. MMSE score between 18 and 26. The patient can fulfil all neuropsychologic test, according to investigator. The patient has to be always with his/her caretaker during monitorization visits The caretaker has to be in regular contact with the patient, knowing his/her situation and participation in the study. The caretaker has to check four times per week, at least, the product intake, as well as the routine medication and his/her dietetic habits. Both caretaker and patient have to be able to complete the product intake during all the length of the study, according to the main investigator. Exclusion Criteria: Patient and/or caretaker not being able to understand and agree in writing their participation in the study. Patient disability to oral intake of products. Known allergy to any of the product components (active and placebo) Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression. regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion. Any known concurrent malignant pathology in the moment of study inclusion, or severe metabolic, cardiovascular, renal, hepatic, or gastrointestinal disease that cannot allow the ending of the study according the investigator. Any analytical abnormality during the screening, apart from: Creatinine no less than 1.7 mg/dL; low levels of Vitamin B12, and TSH abnormal values.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lipidic Blend 1<br>Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day | Dietary Supplement: Lipidic Blend 1<br>* daily intake of the content of one 45 mL bottle containing the product<br>|
| Active Comparator: Lipidic Blend 2<br>Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day | Dietary Supplement: Lipidic Blend 2<br>* daily intake of the content of one 45 mL bottle containing the product<br>|
| Placebo Comparator: Placebo<br>Glass bottle with 45 ml of Olive oil. 1 bottle per day | Dietary Supplement: Placebo<br>* daily intake of the content of one 45 mL bottle containing olive oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mini-Mental State Examination (MMSE) score |  | baseline, 3 month, 6 month, 9 month, 12 month | 
| Changes in Global Clinical Dementia Rating (CDR) score |  | baseline, 3 month, 6 month, 9 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde) |  | baseline, 12 month | 
| Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA)) |  | baseline, 12 month | 
| Changes in beta-amyloid protein concentration | Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study. | baseline, 12 month | 
| Changes in TAU-Protein concentration | Changes in mean values on high sensitivity beta-amyloid 1-40 and 1-42 protein and TAU-protein in cerebrospinal fluid on those patients with a new diagnose of mild to moderate cognitive impairment, that require an initial lumbar puncture and a new lumbar puncture to control evolution at the end of teh study. | baseline, 12 month | 
| Changes in regular treatment for the cognitive impairment |  | baseline, 3 month, 6 month, 9 month, 12 month | 
| Changes in dietetic habits |  | baseline, 3 month, 6 month, 9 month, 12 month | 
| Changes in Barthel score |  | baseline, 3 month, 6 month, 9 month, 12 month | 
| Changes in Morisky-Green score |  | baseline, 3 month, 6 month, 9 month, 12 month | 
| changes in weight |  | baseline, 3 month, 6 month, 9 month, 12 month | 
| Number of adverse events | Number of adverse events related or nonrelated to the study or placebo products. | baseline, 3 month, 6 month, 9 month, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Impairment, Alzheimer's Disease, Vegetal Oil