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

July 16, 2015 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain
        • Amma Argaray
      • Pamplona, Navarra, Spain
        • AMMA Mutilva
      • Pamplona, Navarra, Spain
        • AMMA Oblatas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dietary Supplement capsule
One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation
Dietary supplement: Omega-3 fatty acid supplementation
Gelatine capsule, 1 at each meals (3 per day) during one year
Placebo Comparator: Empty gelatine capsule
One capsule at meals (3 each day during 1 year)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State Examination
Time Frame: 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.
Six months / one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Joaquin Baleztena, MD, Clinica Universidad de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 20, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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