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Completed

NCT Number: NCT00746005

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Gelderse Vallei, Ede, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

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

placebo, sunflower oil

Dietary Supplement

3 g of sunflower oil

Primary outcomes

  1. cognitive performance

    Time frame: baseline and after 4 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Radboud University Medical Center

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2008
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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