Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-13 @ 12:50 AM
Study NCT ID:
NCT02331667
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Diet on Learning Abilities for Children in Kindergarden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017747', 'term': 'Seafood'}], 'ancestors': [{'id': 'D008460', 'term': 'Meat'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WPSSI-III and Nine Hole peg test.', 'timeFrame': '5 months', 'description': 'The intervention study aims to test the effect of diet on improvement in cognitive performance measured by WPPSSI-III and Nine Hope Peg test in kindergarten children.'}], 'secondaryOutcomes': [{'measure': 'Mercury', 'timeFrame': '5 months', 'description': 'Total hair mercury concentration'}, {'measure': 'Mental health', 'timeFrame': '5 months', 'description': 'Strengths and difficulties questionnaire (SDQ)'}, {'measure': 'Sleep', 'timeFrame': '5 months', 'description': 'Questionnaire report by parent'}, {'measure': 'B-vitamines', 'timeFrame': '5 months', 'description': 'Serum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate'}, {'measure': 'Cholline pathway', 'timeFrame': '5 months', 'description': 'Serum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO'}, {'measure': 'Tryptophan pathway', 'timeFrame': '5 months', 'description': 'Serum: 3-Hydroxyanthranilic acids, 3-Hydroxykynurenine, Anthranilic acid, Kynurenic acid, Kynurenine, Tryptophan, Xanthurenic acid, Nicotinamide, Picolinic acid, Quinolic acid c acid,'}, {'measure': 'Amino acids', 'timeFrame': '5 months', 'description': 'Serum: 1-MH, 3-MH, ADMa, Alanine, Arginine, Asparagine, Aspartic acid, Cystathionine, Glutamic acid, Glutamine, Histidine, Homoarginine, Isoleucine, Leucine, Lysine, Methionine, Methionine sulfoxide, Ornithine, Phenylalanine, Proline, SDMA, Threonine, Total Cysteine, Trimethyllysine, Tyrosine, Valine'}, {'measure': 'Inflammation', 'timeFrame': '5 months', 'description': 'Serum: Kynureine/Tryptophan-ratio, Neopterin, PAr index'}, {'measure': 'Creatinine', 'timeFrame': '5 months', 'description': 'Serum Creatinine'}, {'measure': 'Fatty acids', 'timeFrame': '5 months', 'description': 'RBC: C16:3n3 (HTA), C20:5n3 (EPA), C22:6n3 (DHA), Sum n-3, C18:2n6 (LA), C30:3n6 (ETE), C20:4n6 (AA), C22:4n\\& (AdA), Sum n-6, Ratio n-3/n-6, C14:0, C16:0, C18:0, C22:0, C16:1, C18:1, C24:1n9'}, {'measure': 'Ferritin', 'timeFrame': '5 months', 'description': 'Serum ferritin'}, {'measure': '25-hydroxyvitamin D', 'timeFrame': '5 months', 'description': 'serum 25(OH)D3'}, {'measure': 'Iodine concentration', 'timeFrame': '5 months', 'description': 'Urinary iodine concentration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet', 'Vitamin-D', 'Meat', 'Fatty fish', 'Iodine', 'fatty acid', 'Intervention study', 'Wechsler Preschool and Primary Scale of Intelligence', 'Strengths and Difficulties Questionnaire', 'Nine hole peg test'], 'conditions': ['Cognitive Performance']}, 'referencesModule': {'references': [{'pmid': '33978160', 'type': 'DERIVED', 'citation': 'Solvik BS, Oyen J, Kvestad I, Markhus MW, Ueland PM, McCann A, Strand TA. Biomarkers and Fatty Fish Intake: A Randomized Controlled Trial in Norwegian Preschool Children. J Nutr. 2021 Aug 7;151(8):2134-2141. doi: 10.1093/jn/nxab112.'}, {'pmid': '32338756', 'type': 'DERIVED', 'citation': 'Solvik BS, Strand TA, Kvestad I, Markhus MW, Ueland PM, McCann A, Oyen J. Dietary Intake and Biomarkers of Folate and Cobalamin Status in Norwegian Preschool Children: The FINS-KIDS Study. J Nutr. 2020 Jul 1;150(7):1852-1858. doi: 10.1093/jn/nxaa111.'}, {'pmid': '29530020', 'type': 'DERIVED', 'citation': 'Oyen J, Kvestad I, Midtbo LK, Graff IE, Hysing M, Stormark KM, Markhus MW, Baste V, Froyland L, Koletzko B, Demmelmair H, Dahl L, Lie O, Kjellevold M. Fatty fish intake and cognitive function: FINS-KIDS, a randomized controlled trial in preschool children. BMC Med. 2018 Mar 12;16(1):41. doi: 10.1186/s12916-018-1020-z.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this intervention study is to test the effect of diet on improvement in cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly allocated into two groups, one consuming prepared meals with herring or mackerel for four months, and one group consuming meals containing meat as a control group.', 'detailedDescription': "Positive effects of n-3 long chain polyunsaturated fatty acids (PUFAs), as provided by fatty fish intake, on cognitive functions are widely accepted, but so far there is no clear evidence from randomized intervention studies in children and young adults, although fish intake has been positively associated with cognitive functions in observational studies. The main aim of this study is to test the effect of diet on improvement in cognitive performance in kindergarden children aged 4-6 years. In the intervention study, children will be randomly allocated into two groups, one consuming prepared meals with herring or mackerel for four months, and one group consuming meals containing meat as a control group. The children (n=200) will consume the prepared meals three times a week. Cognitive performance of the children will be tested at study start and end using the the Wechsler Preschool and Primary Scale of Intelligence (WPPSI\\_III) and nine hole peg test. Children will be screened for mental health problems in the Strengths and Difficulties Questionnaire (SDQ), which is a global measure of children's mental health. Compliance will be monitored by documentation of study fish intake and measuring fatty acid status. For a more detailed investigation of effects of increased herring and mackerel intake, before and after intervention blood and urine will be collected for lipidomic analysis (metabolites), vitamin D and iodine determination and genotyping (fatty acid metabolism and inflammation)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 4-6 years old.\n* Sufficient command of the Norwegian language of child to participate in cognitive testing and of child and parents to comply with study requirements according to investigators estimation.\n\nExclusion Criteria:\n\n* Known food allergies'}, 'identificationModule': {'nctId': 'NCT02331667', 'briefTitle': 'The Effect of Diet on Learning Abilities for Children in Kindergarden', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Nutrition and Seafood Research, Norway'}, 'officialTitle': 'The Effect of Diet on Learning Abilities for Children in Kindergarden', 'orgStudyIdInfo': {'id': '2014/1396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seafood', 'description': 'Intervention with meals consisting of seafood (herring and mackrell).', 'interventionNames': ['Other: Seafood']}, {'type': 'EXPERIMENTAL', 'label': 'Non-seafood', 'description': 'Intervention with meals constisting of non-seafood (meat).', 'interventionNames': ['Other: Non-seafood']}], 'interventions': [{'name': 'Seafood', 'type': 'OTHER', 'description': 'The aim is to investigate the effect of meals consisting of mackrel and herring on learning abilities by using a two-armed individually randomized non-blinded intervention trial.', 'armGroupLabels': ['Seafood']}, {'name': 'Non-seafood', 'type': 'OTHER', 'description': 'The aim is to investigate the effect of meals consisting of meat on learning abilities by using a two-armed individually randomized non-blinded intervention trial.', 'armGroupLabels': ['Non-seafood']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5817', 'city': 'Bergen', 'country': 'Norway', 'facility': 'NIFES', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Ingvild Eide Graff, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'From study start until 2023', 'ipdSharing': 'YES', 'description': 'The results will be published in international journals.', 'accessCriteria': 'Upon request to the project manager.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Nutrition and Seafood Research, Norway', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Scientist', 'investigatorFullName': 'Jannike Øyen', 'investigatorAffiliation': 'National Institute of Nutrition and Seafood Research, Norway'}}}}