Overview

This trial is active, not recruiting.

Condition cognitive enhancement
Treatments fish meals, placebo
Sponsor Ludwig-Maximilians - University of Munich
Collaborator National Institute of Nutrition and Seafood Research, Norway
Start date September 2013
End date October 2015
Trial size 200 participants
Trial identifier NCT01951937, FINS-547

Summary

In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of herring and mackerel will improve cognitive performance of children aged 4 years to 5 years 8 months in the Munich area (Germany), who habitually consume little fish.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
3 Fish meals per week for 4 months
fish meals
Herring and Mackerel Meals
(Placebo Comparator)
Habitual diet
placebo
No fish meals

Primary Outcomes

Measure
Change in Cognitive Performance
time frame: Change from baseline at 4 months later

Secondary Outcomes

Measure
Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage
time frame: Change from baseline at 4 months later
Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3
time frame: Change from baseline at 4 months later
Change of iodine levels in urine
time frame: Change from baseline at 4 months later

Eligibility Criteria

Male or female participants from 4 years up to 6 years old.

Inclusion Criteria: - 4-6 years Exclusion Criteria: - severe illness - child dislikes fish

Additional Information

Official title Herring and Mackerel Intervention and Learning Abilities in German Youths
Description Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.