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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01817101
• Other study ID #: DIET
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2013
• Last updated: July 16, 2015
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2013
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• Omega-3 fatty acid supplementation
Gelatine capsule, 1 at each meals (3 per day) during one year

Locations

Country	Name	City	State
Spain	Amma Argaray	Pamplona	Navarra
Spain	AMMA Mutilva	Pamplona	Navarra
Spain	AMMA Oblatas	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 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.	Six months / one year	No
Secondary	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	No
Secondary	Verbal fluency test	Category verbal fluency test. Rosen W.: "Verbal fluency in aging and dementia". J. Clin Neuropsychol 1980;2: 135-146.	One year	No
Secondary	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	No