Fish Intervention and Learning Abilities

Cognitive Enhancement Clinical Trial

— FINS  

Official title:

Fish Intervention and Learning Abilities in German Youths

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951937
• Other study ID #: FINS-547
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2019

Study information

• Verified date: August 2022
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• 4-6 years

Exclusion Criteria:

• severe illness
• child dislikes fish

Related Conditions & MeSH terms

• Cognitive Enhancement

Intervention

Dietary Supplement:
• Fish Meals
Meals containing salmon
• Placebo
No fish meals

Locations

Country	Name	City	State
Germany	Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	National Institute of Nutrition and Seafood Research, Norway

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Demmelmair H, Øyen J, Pickert T, Rauh-Pfeiffer A, Stormark KM, Graff IE, Lie Ø, Kjellevold M, Koletzko B. The effect of Atlantic salmon consumption on the cognitive performance of preschool children - A randomized controlled trial. Clin Nutr. 2019 Dec;38( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Performance		Change from baseline at 4 months later
Secondary	Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage		Change from baseline at 4 months later
Secondary	Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3		Change from baseline at 4 months later
Secondary	Change of iodine levels in urine		Change from baseline at 4 months later

External Links

•   Contact Information Prof. Dr. Berthold Koletzko