Mild Cognitive ImpairmentNCT00746005
Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
A study testing fish oil in people with Mild Cognitive Impairment, run by Wageningen University at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- fish oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Ziekenhuis Gelderse Vallei
Ede, Gelderland, 6710 HN
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GC
About this study
Official title: 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- fish oil, placebo, sunflower oil
- Keywords
- mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg
placebo, sunflower oilDietary supplement
3 g of sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 g EPA-DHA Receives: Dietary Supplement: fish oil |
| 2 | Placebo comparator | Placebo: sunflower oil Receives: Dietary Supplement: placebo, sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive performance
Measured: baseline and after 4 weeks
Secondary outcomes (1)
blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS
Measured: baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746005
- Sponsor's protocol ID
- 2008/112
- Status last verified
- Jan 2011
- First submitted
- 30 Aug 2008
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele
- ClinicalTrials.gov ID
- NCT00746005
- Acronym / sponsor ID
- 2008/112
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- Oct 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: fish oil3 g EPA-DHA |
| 2 | Placebo comparator | Dietary Supplement: placebo, sunflower oilPlacebo: sunflower oil |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish oil3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg | Dietary supplement | 1 |
| placebo, sunflower oil3 g of sunflower oil | Dietary supplement | 2 |
Primary outcome
cognitive performance
Time frame: baseline and after 4 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil in people with Mild Cognitive Impairment, run by Wageningen University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive performance (time frame: baseline and after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.