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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

Tracking Information
First Submitted Date  ICMJE August 30, 2008
First Posted Date  ICMJE September 3, 2008
Last Update Posted Date January 12, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
cognitive performance [ Time Frame: baseline and after 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
Official Title  ICMJE Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    3 g EPA-DHA
    Intervention: Dietary Supplement: fish oil
  • Placebo Comparator: 2
    Placebo: sunflower oil
    Intervention: Dietary Supplement: placebo, sunflower oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 2, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746005
Other Study ID Numbers  ICMJE 2008/112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisette de Groot, Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE Radboud University
Investigators  ICMJE Not Provided
PRS Account Wageningen University
Verification Date January 2011

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