- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00746005
Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
January 11, 2011 updated by: Wageningen University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Ede, Gelderland, Netherlands, 6710 HN
- Ziekenhuis Gelderse Vallei
-
Nijmegen, Gelderland, Netherlands, 6525 GC
- Radboud University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
3 g EPA-DHA
|
3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
|
Placebo Comparator: 2
Placebo: sunflower oil
|
3 g of sunflower oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cognitive performance
Time Frame: baseline and after 4 weeks
|
baseline and after 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline and after 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 30, 2008
First Submitted That Met QC Criteria
September 2, 2008
First Posted (Estimate)
September 3, 2008
Study Record Updates
Last Update Posted (Estimate)
January 12, 2011
Last Update Submitted That Met QC Criteria
January 11, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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