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| Name | Class |
|---|---|
| Biopolis S.L. | INDUSTRY |
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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipidic Blend 1 | Active Comparator | Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day |
|
| Lipidic Blend 2 | Active Comparator | Glass bottle with 45 ml of vegetal mixture oil. 1 bottle per day |
|
| Placebo | Placebo Comparator | Glass bottle with 45 ml of Olive oil. 1 bottle per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipidic Blend 1 | Dietary Supplement | daily intake of the content of one 45 mL bottle containing the product |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicente Navarro-López, MD | Contact | vnavarro@ucam.edu | ||
| Miguel A Carrión-Gutiérrez, PhD | Contact | miguelcarrion65@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vicente Navarro-López, MD | Universidad Católica San Antonio de Murcia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Vinalopó | Recruiting | Elche | Alicante | 03293 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22792378 | Background | Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11. | |
| 20150735 | Background | Luck T, Luppa M, Briel S, Riedel-Heller SG. Incidence of mild cognitive impairment: a systematic review. Dement Geriatr Cogn Disord. 2010;29(2):164-75. doi: 10.1159/000272424. Epub 2010 Feb 11. |
| Label | URL |
|---|---|
| World Health Organization. Dementia. Fact sheet 362. Published March 2015 | View source |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| Lipidic Blend 2 | Dietary Supplement | daily intake of the content of one 45 mL bottle containing the product |
|
| Placebo | Dietary Supplement | daily intake of the content of one 45 mL bottle containing olive oil |
|
| 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 |
| Hospital Universitario de Torrevieja | Recruiting | Torrevieja | Alicante | 03186 | Spain |
|
| Background | Coronado M, et al. Los ácidos grasos omega-3 y omega-6: Nutrición, bioquímica y salud. REB 25(3) 2006: 72-79 |
| 22332096 | Background | Swanson D, Block R, Mousa SA. Omega-3 fatty acids EPA and DHA: health benefits throughout life. Adv Nutr. 2012 Jan;3(1):1-7. doi: 10.3945/an.111.000893. Epub 2012 Jan 5. |
| 22932777 | Background | Lee LK, Shahar S, Chin AV, Yusoff NA. Docosahexaenoic acid-concentrated fish oil supplementation in subjects with mild cognitive impairment (MCI): a 12-month randomised, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2013 Feb;225(3):605-12. doi: 10.1007/s00213-012-2848-0. Epub 2012 Aug 30. |
| 15543423 | Background | Larrieu S, Letenneur L, Berr C, Dartigues JF, Ritchie K, Alperovitch A, Tavernier B, Barberger-Gateau P. Sociodemographic differences in dietary habits in a population-based sample of elderly subjects: the 3C study. J Nutr Health Aging. 2004;8(6):497-502. |
| 17435956 | Background | Gillette Guyonnet S, Abellan Van Kan G, Andrieu S, Barberger Gateau P, Berr C, Bonnefoy M, Dartigues JF, de Groot L, Ferry M, Galan P, Hercberg S, Jeandel C, Morris MC, Nourhashemi F, Payette H, Poulain JP, Portet F, Roussel AM, Ritz P, Rolland Y, Vellas B. IANA task force on nutrition and cognitive decline with aging. J Nutr Health Aging. 2007 Mar-Apr;11(2):132-52. |
| 14653768 | Background | Logan AC. Neurobehavioral aspects of omega-3 fatty acids: possible mechanisms and therapeutic value in major depression. Altern Med Rev. 2003 Nov;8(4):410-25. |
| 15129302 | Background | Bourre JM. Roles of unsaturated fatty acids (especially omega-3 fatty acids) in the brain at various ages and during ageing. J Nutr Health Aging. 2004;8(3):163-74. |
| El deterioro cognitivo leve (DCL) en la edad de oro | View source |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |