This trial is active, not recruiting.

Condition mild cognitive impairment
Treatment omega-3 fatty acid supplementation
Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Start date January 2012
End date October 2015
Trial size 170 participants
Trial identifier NCT01817101, DIET


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
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
(Placebo Comparator)
One capsule at meals (3 each day during 1 year)

Primary Outcomes

Mini Mental State Examination
time frame: Six months / one year

Secondary Outcomes

Short Portable Mental Status Questionnaire (SPMSQ)
time frame: One year
Verbal fluency test
time frame: One year
Clock-drawing test
time frame: One year

Eligibility Criteria

Male or female participants at least 75 years old.

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

Additional Information

Official title Field Trial With Omega-3 Fatty Acid Supplementation for the Prevention of Cognitive Decline in a Very Elderly Population
Principal investigator Joaquin Baleztena, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Clinica Universidad de Navarra, Universidad de Navarra.