Dietary Supplement for the Prevention of Cognitive Decline in a Very Elderly Population.

NCT ID: NCT01817101

Last Updated: 2015-07-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to determine whether an omega-3 fatty acid supplementation is effective in the prevention of progressive cognitive decline in elderly people aged 75 years or older.

Detailed Description

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Participants are residents at three nursing homes in Pamplona (Spain). We assumed that 20% of elderly people have a cognitive decline and we estimated a 5% of cognitive decline in the intervention group. Sample size estimated was 85 participants for each arm, assuming two groups with an alpha of 0.05, 80% power and accounting for 10% of participants lost to follow-up.

Repeated measures ANOVA, Cox regression and multiple linear regression analysis will be used for the statistical analysis of data.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acid supplementation

Intervention Type DIETARY_SUPPLEMENT

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)

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Elderly people aged 75 years or older
* Global Deterioration Scale \< 4
* Capacity to complete the tests

Exclusion Criteria

* Neurological, physical or psychiatry conditions, obtained from the medical history, that may have an influence on the cognitive function.
* Dementia
* History of epilepsy, convulsions
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

AMMA Mutilva

Pamplona, Navarre, Spain

Site Status

AMMA Oblatas

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

Other Identifiers

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DIET

Identifier Type: -

Identifier Source: org_study_id

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