NCT01817101

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

Summary

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

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

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 fatty acid supplementation	Gelatine capsule, 1 at each meals (3 per day) during one year

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2013-03-22
• Last updated: 2015-07-17

Locations

3 sites across 1 country: Spain