Dietary Supplement for the Prevention of Cognitive Decline in a Very Elderly Population.
NCT ID: NCT01817101
Last Updated: 2015-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
170 participants
INTERVENTIONAL
2012-01-31
2015-12-31
Brief Summary
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Detailed Description
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Repeated measures ANOVA, Cox regression and multiple linear regression analysis will be used for the statistical analysis of data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Dietary Supplement capsule
One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation
Omega-3 fatty acid supplementation
Gelatine capsule, 1 at each meals (3 per day) during one year
Empty gelatine capsule
One capsule at meals (3 each day during 1 year)
No interventions assigned to this group
Interventions
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Omega-3 fatty acid supplementation
Gelatine capsule, 1 at each meals (3 per day) during one year
Eligibility Criteria
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Inclusion Criteria
* Global Deterioration Scale \< 4
* Capacity to complete the tests
Exclusion Criteria
* Dementia
* History of epilepsy, convulsions
75 Years
ALL
Yes
Sponsors
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Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
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Principal Investigators
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Joaquin Baleztena, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Universidad de Navarra
Locations
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Amma Argaray
Pamplona, Navarre, Spain
AMMA Mutilva
Pamplona, Navarre, Spain
AMMA Oblatas
Pamplona, Navarre, Spain
Countries
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Other Identifiers
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DIET
Identifier Type: -
Identifier Source: org_study_id
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