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

W

Wageningen University

Status

Completed

Conditions

Mild Cognitive Impairment

Treatments

Dietary Supplement: placebo, sunflower oil
Dietary Supplement: fish oil

Study type

Interventional

Funder types

Other

Identifiers

NCT00746005
2008/112

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
3 g EPA-DHA
Treatment:
Dietary Supplement: fish oil
2
Placebo Comparator group
Description:
Placebo: sunflower oil
Treatment:
Dietary Supplement: placebo, sunflower oil

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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