NCT00615277

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
Last Updated

February 14, 2008

Status Verified

February 1, 2008

Enrollment Period

3 months

First QC Date

February 1, 2008

Last Update Submit

February 13, 2008

Conditions

Healthy

Keywords

Young adultsLong-chain polyunsaturated fatty acidsCognitive functionMoodSupply with omega-3 fatty acids

Outcome Measures

Primary Outcomes (1)

  • Cognition

    Before intervention and after 16 weeks of intervention

Secondary Outcomes (1)

  • Mood

    Before intervention and after 16 weeks of intervention

Study Arms (2)

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

Omega-3 fatty acidsDIETARY_SUPPLEMENT

600 mg EPA 120mg DHA daily, 16 weeks

12

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy young adults

You may not qualify if:

  • Coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Katharina A Widenhorn-Mueller, PhD

    University of Ulm

    PRINCIPAL INVESTIGATOR

  • Ulrike Weiland, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

October 1, 2006

Primary Completion

January 1, 2007

Last Updated

February 14, 2008

Record last verified: 2008-02