We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746005
First Posted: September 3, 2008
Last Update Posted: January 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Radboud University
Information provided by:
Wageningen University
August 30, 2008
September 3, 2008
January 12, 2011
October 2008
January 2011   (Final data collection date for primary outcome measure)
cognitive performance [ Time Frame: baseline and after 4 weeks ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00746005
2008/112
No
Not Provided
Not Provided
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