Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-02 @ 2:54 AM
Study NCT ID:
NCT05773456
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2023-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine Status After Intake of Sushi and Seaweed Salad
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary iodine concentration during 48 hours', 'timeFrame': '48 hours', 'description': 'Urinary iodine concentration after ingestion of the intervention/supplement during 48 hours by fixed time-intervals'}, {'measure': 'Bio-availability of iodine in the intervention/supplement', 'timeFrame': '48 hours', 'description': 'Calculation of the bio-availability of iodine in the intervention/supplement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['seaweed', 'bioavailability', 'iodine'], 'conditions': ['Iodine Deficiency']}, 'descriptionModule': {'briefSummary': 'Seaweed is becoming increasingly popular in the Western part of the world, especially sushi wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine content of different seaweed products in the Norwegian Food composition table. Furthermore, there is limited available research regarding in vivo bioavailability of iodine from seaweeds. The objective of this study is to assess whether iodine from a sushi meal (with nori, Porphyra spp), and a wakame salad (Undaria pinnatifida) has similar bioavailability as a potassium iodide reference supplement of similar iodine content.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women aged 18 to 40 years\n\nExclusion Criteria:\n\n* pregnant or lactating\n* known thyroid disease or thyroid autoimmunity,\n* planning to conceive,\n* known kidney problems or kidney disease.\n* women with coeliac disease could not participate due to possible gluten exposure from the wakame salad'}, 'identificationModule': {'nctId': 'NCT05773456', 'briefTitle': 'Iodine Status After Intake of Sushi and Seaweed Salad', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Iodine Status at Several Time Points During 48 Hours After Intake of Sushi and Seaweed Salad- a Randomized Crossover Trial', 'orgStudyIdInfo': {'id': '232247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sushi and wakame salad', 'description': '231 microgram of iodine per serving', 'interventionNames': ['Other: Sushi and wakame salad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Potassium iodide supplement', 'description': '225 microgram of iodine per tablet', 'interventionNames': ['Other: Sushi and wakame salad']}], 'interventions': [{'name': 'Sushi and wakame salad', 'type': 'OTHER', 'description': 'One serving of mixed sushi and wakame salad', 'armGroupLabels': ['Potassium iodide supplement', 'Sushi and wakame salad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'University of Bergen', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Inger Aakre, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Marine Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Marine Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}