Fish Intervention and Learning Abilities

NCT ID: NCT01951937

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Enhancement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fish Meals

3 Fish meals per week for 4 months

Group Type ACTIVE_COMPARATOR

Fish Meals

Intervention Type DIETARY_SUPPLEMENT

Meals containing salmon

Placebo

Habitual diet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

No fish meals

Interventions

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Fish Meals

Meals containing salmon

Intervention Type DIETARY_SUPPLEMENT

Placebo

No fish meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 4-6 years

Exclusion Criteria

* severe illness
* child dislikes fish
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nutrition and Seafood Research, Norway

OTHER_GOV

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Prof. Berthold Koletzko

Dr med Dr med habil (MD PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berthold Koletzko, Dr med habil

Role: STUDY_DIRECTOR

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

Locations

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

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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Demmelmair H, Oyen J, Pickert T, Rauh-Pfeiffer A, Stormark KM, Graff IE, Lie O, 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(6):2558-2568. doi: 10.1016/j.clnu.2018.11.031. Epub 2018 Dec 22.

Reference Type RESULT
PMID: 30598384 (View on PubMed)

Related Links

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Other Identifiers

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FINS-547

Identifier Type: -

Identifier Source: org_study_id

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