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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: fish oil; Dietary Supplement: placebo, sunflower oil

• Registration Number: NCT00746005
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-30
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Study Start: 2008-10
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-11
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fish oil	3 g EPA-DHA
2	placebo, sunflower oil	Placebo: sunflower oil

Primary Outcome Measures

Name	Time	Method
cognitive performance	baseline and after 4 weeks

Secondary Outcome Measures

Name	Time	Method
blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS	baseline and after 4 weeks

Trial Locations

Locations (2)

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Gelderland, Netherlands