Efficacy of Fish Oil Supplementation on Cognition in MCI... | NCT00746005

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

NCT00746005

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Jan 12, 2011Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Mild Cognitive Impairment

Interventions

fish oil
placebo, sunflower oil

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Aug 30, 2008

First Submission Date that Met QC Criteria

Sep 2, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2011

Last Update Posted Date

Jan 12, 2011Estimated

Name	Class
Radboud University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	3 g EPA-DHA	Dietary Supplement: fish oil
2	Placebo Comparator	Placebo: sunflower oil	Dietary Supplement: placebo, sunflower oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fish oil	Dietary Supplement	3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cognitive performance		baseline and after 4 weeks

Secondary Outcomes

Measure	Description	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		baseline and after 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Gelderse Vallei		Ede	Gelderland	6710 HN	Netherlands
Radboud University Medical Center

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005395	Fish Oils
D000074242	Sunflower Oil

Ancestor Terms

ID	Term
D009821	Oils
D008055	Lipids
D010938	Plant Oils
D028321	Plant Preparations
D001688

Browse Leaves

Not provided

Browse Branches

Not provided