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

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00746005
First received: August 30, 2008
Last updated: January 11, 2011
Last verified: January 2011

August 30, 2008
January 11, 2011
October 2008
January 2011   (final data collection date for primary outcome measure)
cognitive performance [ Time Frame: baseline and after 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746005 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Mild Cognitive Impairment
  • Dietary Supplement: fish oil
    3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
  • Dietary Supplement: placebo, sunflower oil
    3 g of sunflower oil
  • Experimental: 1
    3 g EPA-DHA
    Intervention: Dietary Supplement: fish oil
  • Placebo Comparator: 2
    Placebo: sunflower oil
    Intervention: Dietary Supplement: placebo, sunflower oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00746005
2008/112
No
Lisette de Groot, Wageningen University
Wageningen University
Radboud University
Not Provided
Wageningen University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP