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Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
fish oil
placebo, sunflower oil
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women
  • Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37)
  • Presence of a principal caregiver willing to assist for a successful participation
  • Informed consent signed

Exclusion Criteria:

  • Current or recent (<4 weeks) use of fish oil supplements
  • Consumption of fish more than 2 times/week
  • Current use of dementia (Alzheimer) medication
  • Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil)
  • Serious liver disease
  • Use of more than 4 glasses of alcohol per day
  • Unable to participate as judged by the responsible medical physician
  • Allergy to fish(oil)
  • Swallowing problems
  • Participation in another clinical trial less than 2 months before the start of the trial or at the same time

Sites / Locations

  • Ziekenhuis Gelderse Vallei
  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

3 g EPA-DHA

Placebo: sunflower oil

Outcomes

Primary Outcome Measures

cognitive performance

Secondary Outcome Measures

blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS

Full Information

First Posted
August 30, 2008
Last Updated
January 11, 2011
Sponsor
Wageningen University
Collaborators
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00746005
Brief Title
Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
Official Title
Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wageningen University
Collaborators
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
3 g EPA-DHA
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo: sunflower oil
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil
Intervention Description
3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo, sunflower oil
Intervention Description
3 g of sunflower oil
Primary Outcome Measure Information:
Title
cognitive performance
Time Frame
baseline and after 4 weeks
Secondary Outcome Measure Information:
Title
blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS
Time Frame
baseline and after 4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37) Presence of a principal caregiver willing to assist for a successful participation Informed consent signed Exclusion Criteria: Current or recent (<4 weeks) use of fish oil supplements Consumption of fish more than 2 times/week Current use of dementia (Alzheimer) medication Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil) Serious liver disease Use of more than 4 glasses of alcohol per day Unable to participate as judged by the responsible medical physician Allergy to fish(oil) Swallowing problems Participation in another clinical trial less than 2 months before the start of the trial or at the same time
Facility Information:
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6710 HN
Country
Netherlands
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GC
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.humannutrition.nl
Description
Related Info

Learn more about this trial

Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele

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