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

Alzheimer Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778581
• Other study ID #: ALZ-OIL.01
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2016
• Last updated: June 1, 2016
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2016
• Source: Team Foods Colombia S.A.
• Contact: Vicente Navarro-López, MD
• Email: vnavarro[@]ucam.edu
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Impairments

Intervention

Dietary Supplement:
• Lipidic Blend 1
daily intake of the content of one 45 mL bottle containing the product
• Lipidic Blend 2
daily intake of the content of one 45 mL bottle containing the product
• Placebo
daily intake of the content of one 45 mL bottle containing olive oil

Locations

Country	Name	City	State
Spain	Hospital Universitario Vinalopó	Elche	Alicante
Spain	Hospital Universitario de Torrevieja	Torrevieja,	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Team Foods Colombia S.A.	Biopolis S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. Review. — View Citation

Coronado M, et al. Los ácidos grasos omega-3 y omega-6: Nutrición, bioquímica y salud. REB 25(3) 2006: 72-79

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Mini-Mental State Examination (MMSE) score		baseline, 3 month, 6 month, 9 month, 12 month	No
Primary	Changes in Global Clinical Dementia Rating (CDR) score		baseline, 3 month, 6 month, 9 month, 12 month	No
Secondary	Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)		baseline, 12 month	No
Secondary	Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))		baseline, 12 month	No
Secondary	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	No
Secondary	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	No
Secondary	Changes in regular treatment for the cognitive impairment		baseline, 3 month, 6 month, 9 month, 12 month	No
Secondary	Changes in dietetic habits		baseline, 3 month, 6 month, 9 month, 12 month	No
Secondary	Changes in Barthel score		baseline, 3 month, 6 month, 9 month, 12 month	No
Secondary	Changes in Morisky-Green score		baseline, 3 month, 6 month, 9 month, 12 month	No
Secondary	changes in weight		baseline, 3 month, 6 month, 9 month, 12 month	No
Secondary	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	Yes

External Links

•   El deterioro cognitivo leve (DCL) en la edad de oro
•   World Health Organization. Dementia. Fact sheet 362. Published March 2015