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

Mild Cognitive Impairment Clinical Trial

Official title:

Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746005
• Other study ID #: 2008/112
• Status: Completed
• Phase: N/A
• First received: August 30, 2008
• Last updated: January 11, 2011
• Start date: October 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• fish oil
3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
• placebo, sunflower oil
3 g of sunflower oil

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Gelderse Vallei	Ede	Gelderland
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive performance		baseline and after 4 weeks	No
Secondary	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	No

External Links

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