Study to Evaluate the Effect of a Vegetal Oil on Cognitive Impairment
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.
1 other identifier
interventional
110
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 8, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 3, 2016
May 1, 2016
1.1 years
May 8, 2016
June 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
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
baseline, 12 month
Changes in TAU-Protein concentration
baseline, 12 month
Changes in regular treatment for the cognitive impairment
baseline, 3 month, 6 month, 9 month, 12 month
- +5 more secondary outcomes
Study Arms (3)
Lipidic Blend 1
ACTIVE COMPARATORGlass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
Lipidic Blend 2
ACTIVE COMPARATORGlass bottle with 45 ml of vegetal mixture oil. 1 bottle per day
Placebo
PLACEBO COMPARATORGlass bottle with 45 ml of Olive oil. 1 bottle per day
Interventions
daily intake of the content of one 45 mL bottle containing the product
daily intake of the content of one 45 mL bottle containing the product
daily intake of the content of one 45 mL bottle containing olive oil
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Team Foods Colombia S.A.lead
- Biopolis S.L.collaborator
Study Sites (2)
Hospital Universitario Vinalopó
Elche, Alicante, 03293, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186, Spain
Related Publications (9)
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.
PMID: 22792378BACKGROUNDLuck 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.
PMID: 20150735BACKGROUNDCoronado M, et al. Los ácidos grasos omega-3 y omega-6: Nutrición, bioquímica y salud. REB 25(3) 2006: 72-79
BACKGROUNDSwanson 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.
PMID: 22332096BACKGROUNDLee 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.
PMID: 22932777BACKGROUNDLarrieu 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.
PMID: 15543423BACKGROUNDGillette 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.
PMID: 17435956BACKGROUNDLogan 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.
PMID: 14653768BACKGROUNDBourre 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.
PMID: 15129302BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vicente Navarro-López, MD
Universidad Católica San Antonio de Murcia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2016
First Posted
May 20, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2017
Study Completion
July 1, 2017
Last Updated
June 3, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share