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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01951937
Other study ID # FINS-547
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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