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

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: Omega-3 fatty acid supplementation

• Registration Number: NCT01817101
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief 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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-01
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-07-17
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Supplement capsule	Omega-3 fatty acid supplementation	One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation

Primary Outcome Measures

Name	Time	Method
Mini Mental State Examination	Six months / one year	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.

Secondary Outcome Measures

Name	Time	Method
Short Portable Mental Status Questionnaire (SPMSQ)	One year	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)
Clock-drawing test	One year	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.
Verbal fluency test	One year	Category verbal fluency test. Rosen W.: "Verbal fluency in aging and dementia". J. Clin Neuropsychol 1980;2: 135-146.

Trial Locations

Locations (3)

Amma Argaray; 🇪🇸 Pamplona, Navarra, Spain

AMMA Mutilva; 🇪🇸 Pamplona, Navarra, Spain

AMMA Oblatas; 🇪🇸 Pamplona, Navarra, Spain