Fish Intervention and Learning Abilities (FINS)

August 18, 2022 updated by: Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

Fish Intervention and Learning Abilities in German Youths

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80337
        • Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 4-6 years

Exclusion Criteria:

  • severe illness
  • child dislikes fish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fish Meals
3 Fish meals per week for 4 months
Dietary supplement: Fish Meals
Meals containing salmon
Placebo Comparator: Placebo
Habitual diet
Dietary supplement: Placebo
No fish meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Cognitive Performance
Time Frame: Change from baseline at 4 months later
Change from baseline at 4 months later

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage
Time Frame: Change from baseline at 4 months later
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 from baseline at 4 months later
Change of iodine levels in urine
Time Frame: Change from baseline at 4 months later
Change from baseline at 4 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

National Institute of Nutrition and Seafood Research, Norway

Investigators

  • Study Director: Berthold Koletzko, Dr med habil, Head, Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre - Klinikum d. Univ. München Lindwurmstr. 4, D-80337 Muenchen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FINS-547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Enhancement

Clinical Trials on Fish Meals

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe