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

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ClinicalTrials.gov Identifier: NCT00746005
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : January 12, 2011
Sponsor:
Collaborator:
Radboud University
Information provided by:
Wageningen University

Brief Summary:
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 or disease Intervention/treatment Phase
Mild Cognitive Impairment Dietary Supplement: fish oil Dietary Supplement: placebo, sunflower oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cognitive performance [ Time Frame: baseline and after 4 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier: NCT00746005     History of Changes
Other Study ID Numbers: 2008/112
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011

Keywords provided by Wageningen University:
mild cognitive impairment

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders