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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement capsule | Active Comparator | One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation |
|
| Empty gelatine capsule | Placebo Comparator | One capsule at meals (3 each day during 1 year) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid supplementation | Dietary Supplement | Gelatine capsule, 1 at each meals (3 per day) during one year |
|
| 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, DÃaz 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Baleztena, MD | Clinica Universidad de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amma Argaray | Pamplona | Navarre | Spain | |||
| AMMA Mutilva |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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 |
| Pamplona |
| Navarre |
| Spain |
| AMMA Oblatas | Pamplona | Navarre | Spain |