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

Study Overview
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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.

Official Title
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Field Trial With Omega-3 Fatty Acid Supplementation for the Prevention of Cognitive Decline in a Very Elderly Population

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: Omega-3 fatty acid supplementation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Supplement capsule<br>One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation | Dietary Supplement: Omega-3 fatty acid supplementation<br>* Gelatine capsule, 1 at each meals (3 per day) during one year<br>|
| Placebo Comparator: Empty gelatine capsule<br>One capsule at meals (3 each day during 1 year) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental State Examination | MMSE is a brief questionnaire test that is used to screen for cognitive impairment. A validated test in Spanish will be used: Lobo A. Saza P. Marcos G, Díaz J, De la Cámara C, Ventura T et al: Revalidación y normalización del Mini-Examen Cogniscitivo (primera versión en castellano del Mini-Mental Status Examination) en la población general geriátrica. Med Clin (Barc) 1999;112:767-774. | Six months / one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Portable Mental Status Questionnaire (SPMSQ) | A questionnaire for the assessment of organic brain deficit in elderly patients (Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975;23:433-41) | One year | 
| Verbal fluency test | Category verbal fluency test. Rosen W.: Verbal fluency in aging and dementia. J. Clin Neuropsychol 1980;2: 135-146. | One year | 
| Clock-drawing test | A cognitive test that covers a wide range of cognitive function. Battersby, W.S., Bender, M.B., Pollack, M. y Kahn, R.L. Unilateral spatial agnosia (inattention) in patients with cortical lesions. Brain 1956; 79: 68-93. | One year |