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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
History of Changes
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
 Dietary Supplement: fish oil
Dietary Supplement: placebo, sunflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • cognitive performance [ Time Frame: baseline and after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3 g EPA-DHA
 Dietary Supplement: fish oil
3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
Placebo Comparator: 2
Placebo: sunflower oil
 Dietary Supplement: placebo, sunflower oil
3 g of sunflower oil

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746005

Locations
Netherlands
Ziekenhuis Gelderse Vallei
Ede, Gelderland, Netherlands, 6710 HN
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GC
Sponsors and Collaborators
Wageningen University
Radboud University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier: NCT00746005     History of Changes
Other Study ID Numbers: 2008/112
Study First Received: August 30, 2008
Last Updated: January 11, 2011
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Wageningen University:
mild cognitive impairment

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013