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

NCT ID: NCT00746005

Last Updated: 2011-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

3 g EPA-DHA

Group Type EXPERIMENTAL

fish oil

Intervention Type DIETARY_SUPPLEMENT

3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg

2

Placebo: sunflower oil

Group Type PLACEBO_COMPARATOR

placebo, sunflower oil

Intervention Type DIETARY_SUPPLEMENT

3 g of sunflower oil

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fish oil

3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg

Intervention Type DIETARY_SUPPLEMENT

placebo, sunflower oil

3 g of sunflower oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wageningen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ziekenhuis Gelderse Vallei

Ede, Gelderland, Netherlands

Site Status

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008/112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

n-3 PUFA for Vascular Cognitive Aging
NCT01953705 UNKNOWN PHASE2
Fish Oil Brain Delivery Study
NCT02541929 COMPLETED PHASE2/PHASE3