The Effect of Long-Chain Polyunsaturated Fatty Acids on C... | NCT00615277

Studies
The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood

NCT00615277

Sponsor

University of Ulm

Status

Completed

Last Update Posted

Feb 14, 2008Estimated

Enrollment

82Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Omega-3 fatty acids

Countries

Not provided

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

ID	Type	Description	Link
213/2005

Status Module

Record Verification Date

Feb 2008

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 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Feb 1, 2008

First Submission Date that Met QC Criteria

Feb 13, 2008

First Posted Date

Feb 14, 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

Feb 13, 2008

Last Update Posted Date

Feb 14, 2008Estimated

Name	Class
Philipps University Marburg	OTHER
Cognitive Drug Research Ltd	UNKNOWN

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

The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults.

Detailed Description

The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series are building blocks of all cell membranes and are found in high concentrations in retina and brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision with the long-chained omega-3 molecules depends primarily on individual eating habits. While AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations only in certain species of fatty fish, such as salmon or mackerel.

The study investigates whether participants receiving an omega-3 supplement over a period of 4 month, perform better on a series of cognitive tests, than the participants allocated to the placebo group.

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	1: omega-3 fatty acid supplement	Dietary Supplement: Omega-3 fatty acids
2	Placebo Comparator	2: olive oil	Dietary Supplement: Omega-3 fatty acids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 fatty acids	Dietary Supplement	600 mg EPA 120mg DHA daily, 16 weeks	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognition		Before intervention and after 16 weeks of intervention

Secondary Outcomes

Measure	Description	Time Frame
Mood		Before intervention and after 16 weeks of intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy young adults

Exclusion Criteria:

Coagulation disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katharina A Widenhorn-Mueller, PhD	University of Ulm	Principal Investigator
Ulrike Weiland, MD	University of Ulm	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015525	Fatty Acids, Omega-3

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided