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Completed

NCT Number: NCT01951937

Fish Intervention and Learning Abilities

In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.

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Key information

Conditions

Cognitive Enhancement

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre

Munich, Bavaria, 80337, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4-6 years

Exclusion criteria

  • severe illness
  • child dislikes fish

Treatment and study plan

Fish Meals

Dietary Supplement

Meals containing salmon

Placebo

Dietary Supplement

No fish meals

Primary outcomes

  1. Change in Cognitive Performance

    Time frame: Change from baseline at 4 months later

Secondary outcomes

  1. Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage

    Time frame: Change from baseline at 4 months later

  2. 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

  3. Change of iodine levels in urine

    Time frame: Change from baseline at 4 months later

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • National Institute of Nutrition and Seafood Research, Norway

Registry information

Official study title

Fish Intervention and Learning Abilities in German Youths

Acronym: FINS

Important dates

Study start
2014
Primary completion
2015
Study completion
2019
First posted
Sep 27, 2013
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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