NCT01951937

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

September 20, 2013

Last Update Submit

August 18, 2022

Conditions

Cognitive Enhancement

Keywords

Cognitive TestOmega-3 Fatty acids

Outcome Measures

Primary Outcomes (1)

  • Change in Cognitive Performance

    Change from baseline at 4 months later

Secondary Outcomes (3)

  • Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage

    Change from baseline at 4 months later

  • Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3

    Change from baseline at 4 months later

  • Change of iodine levels in urine

    Change from baseline at 4 months later

Study Arms (2)

Fish Meals

ACTIVE COMPARATOR

3 Fish meals per week for 4 months

Dietary Supplement: Fish Meals

Placebo

PLACEBO COMPARATOR

Habitual diet

Dietary Supplement: Placebo

Interventions

Fish MealsDIETARY_SUPPLEMENT

Meals containing salmon

Fish Meals
PlaceboDIETARY_SUPPLEMENT

No fish meals

Placebo

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years

You may not qualify if:

  • severe illness
  • child dislikes fish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 80337, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30598384RESULT

Related Links

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr med Dr med habil (MD PhD)

Study Record Dates

First Submitted

September 20, 2013

First Posted

September 27, 2013

Study Start

September 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2019

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations

DE(1)