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Fish Intervention and Learning Abilities (FINS)

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ClinicalTrials.gov Identifier: NCT01951937
Recruitment Status : Active, not recruiting
First Posted : September 27, 2013
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
National Institute of Nutrition and Seafood Research, Norway
Information provided by (Responsible Party):
Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Cognitive Enhancement Dietary Supplement: Fish Meals Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fish Intervention and Learning Abilities in German Youths
Actual Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : December 2018

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




Primary Outcome Measures :
  1. Change in Cognitive Performance [ Time Frame: Change from baseline at 4 months later ]

Secondary Outcome Measures :
  1. Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage [ Time Frame: Change from baseline at 4 months later ]
  2. 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 ]
  3. Change of iodine levels in urine [ Time Frame: Change from baseline at 4 months later ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 4-6 years

Exclusion Criteria:

  • severe illness
  • child dislikes fish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951937


Locations
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Germany
Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre
Munich, Bavaria, Germany, 80337
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
National Institute of Nutrition and Seafood Research, Norway
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Berthold Koletzko, Dr med Dr med habil (MD PhD), Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01951937    
Other Study ID Numbers: FINS-547
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Keywords provided by Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich:
Cognitive Test
Omega-3 Fatty acids