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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Omega-3 fatty acid supplementation
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Amma Argaray
  • AMMA Mutilva
  • AMMA Oblatas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dietary Supplement capsule

Empty gelatine capsule

Arm Description

One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation

One capsule at meals (3 each day during 1 year)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Verbal fluency test
Category verbal fluency test. Rosen W.: "Verbal fluency in aging and dementia". J. Clin Neuropsychol 1980;2: 135-146.
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.

Full Information

First Posted
March 20, 2013
Last Updated
July 16, 2015
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT01817101
Brief Title
Dietary Supplement for the Prevention of Cognitive Decline in a Very Elderly Population.
Official Title
Field Trial With Omega-3 Fatty Acid Supplementation for the Prevention of Cognitive Decline in a Very Elderly Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement capsule
Arm Type
Active Comparator
Arm Description
One capsule at meals (3 each day) during 1 year with Omega-3 fatty acid supplementation
Arm Title
Empty gelatine capsule
Arm Type
Placebo Comparator
Arm Description
One capsule at meals (3 each day during 1 year)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid supplementation
Intervention Description
Gelatine capsule, 1 at each meals (3 per day) during one year
Primary Outcome Measure Information:
Title
Mini Mental State Examination
Description
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.
Time Frame
Six months / one year
Secondary Outcome Measure Information:
Title
Short Portable Mental Status Questionnaire (SPMSQ)
Description
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)
Time Frame
One year
Title
Verbal fluency test
Description
Category verbal fluency test. Rosen W.: "Verbal fluency in aging and dementia". J. Clin Neuropsychol 1980;2: 135-146.
Time Frame
One year
Title
Clock-drawing test
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquin Baleztena, MD
Organizational Affiliation
Clinica Universidad de Navarra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amma Argaray
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
AMMA Mutilva
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
AMMA Oblatas
City
Pamplona
State/Province
Navarra
Country
Spain

12. IPD Sharing Statement

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

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