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

University of Navarra

Status

Unknown

Conditions

Mild Cognitive Impairment

Treatments

Dietary Supplement: Omega-3 fatty acid supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT01817101

DIET

Details and patient eligibility

About

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.

Full description

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.

Enrollment

170 estimated patients

Sex

All

Ages

75+ years old

Volunteers

Accepts Healthy Volunteers

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