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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00746005

Enrollment

Registered

2008-09-03

Start date

2008-10-31

Completion date

2011-01-31

Last updated

2011-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment

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.

Interventions

DIETARY_SUPPLEMENTfish oil

3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg

DIETARY_SUPPLEMENTplacebo, sunflower oil

3 g of sunflower oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
cognitive performance	baseline and after 4 weeks

Secondary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026