Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT06775795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Bioavailability of Iodine in Plant-based Milk Alternatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041942', 'term': 'Soy Milk'}, {'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D003611', 'term': 'Dairy Products'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary iodine excretion', 'timeFrame': 'A single spot-urine sample collected on days: 2, 9, 16 Urine collected for 24 hours after consumption of test drink on days: 3, 10, 17', 'description': '1 sport urine sample will be collected the day before test drink consumption and a 24-hour urine sample will be collected following the test drink consumption.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iodine bioavailability', 'iodine', 'milk', 'plant-based'], 'conditions': ['Iodine Deficiency']}, 'descriptionModule': {'briefSummary': "Iodine is a mineral commonly found in seafood and dairy products such as milk and cheese. Iodine is important as it is required to make thyroid hormones which regulate growth and metabolism at all stages of life. The UK population has been iodine-sufficient for many years, however, there is now concern that iodine deficiency may be more prevalent than previously thought. This is a concern because iodine deficiency during pregnancy can result in cognitive impairment and developmental delays in children.\n\nThis study will to measure the ability to absorb iodine from plant-based milk alternatives fortified with iodine and compare with cow's milk in adults. Knowing the actual iodine bioavailability from plant-based alternatives is important because plant-based milk alternatives are becoming increasingly popular, especially in young adults, and are used as a replacement for cow's milk.\n\nIn this study, participants will consume three test drinks (cow's milk, soya milk and oat milk), one per week. The study will start with the cows' milk and the other two drinks will be administered in a random order with a crossover design. We will ask participants to follow a low iodine diet for three days leading up to the test day where they will drink one of the test drinks. Participants will then keep a food diary and collect their urine for the following 24 hours. Participants will then go back to their usual diet for at least four days before starting the next arm of the study with another test drink. This data will be used to calculate how much iodine was absorbed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-reported healthy adults\n* Aged 18+\n* English speakers\n* Signed consent form\n* No allergies or intolerances to the study drinks\n* Not following a vegan diet (participants will be required to drink cow's milk)\n\nExclusion Criteria:\n\n* Pregnancy or lactating (according to the participants own statement)\n* Living outside of the UK\n* Involvement in another research study where diet is restricted or modified\n* History of thyroid disease (according to the participants own statement)\n* Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)\n* Use of iodine containing supplements within 1 week prior to study start\n* Inadequate (\\<70 µg/day) or excessive (\\>500 µg/day) iodine intake from food (assessed during screening with previously validated iodine-specific FFQ)\n* Use of iodine-containing disinfectants (betadine)\n* Exposure to iodine-containing X-ray/ computed tomography contrast agent within the last month"}, 'identificationModule': {'nctId': 'NCT06775795', 'acronym': 'IoBIO', 'briefTitle': 'The Bioavailability of Iodine in Plant-based Milk Alternatives', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': 'The Bioavailability of Iodine in Plant-based Milk Alternatives', 'orgStudyIdInfo': {'id': 'FHMS 23-24 161 EGA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Cow's milk", 'description': 'Semi-Skimmed UHT Milk (estimated iodine concentration: 350 µg/L) providing approximately 200 µg of iodine (approx. 570mL).', 'interventionNames': ["Dietary Supplement: Cow's milk"]}, {'type': 'EXPERIMENTAL', 'label': 'Oat milk alternative', 'description': 'Oat Drink (estimated iodine concentration: 370 µg/L) providing approximately 200 µg of iodine (approx. 545mL).', 'interventionNames': ['Dietary Supplement: Oat milk']}, {'type': 'EXPERIMENTAL', 'label': 'Soya milk alternative', 'description': 'Soya Drink (estimated iodine concentration: 460 µg/L) providing approximately 200 µg of iodine (approx. 435mL).', 'interventionNames': ['Dietary Supplement: Soya milk']}], 'interventions': [{'name': 'Oat milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will consume one portion of plant-based milk alternative (oat) which will provide approximately 200 µg of iodine', 'armGroupLabels': ['Oat milk alternative']}, {'name': 'Soya milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will consume one portion of plant-based milk alternative (soya) which will provide approximately 200 µg of iodine', 'armGroupLabels': ['Soya milk alternative']}, {'name': "Cow's milk", 'type': 'DIETARY_SUPPLEMENT', 'description': "Participants will consume one portion of semi-skimmed cow's milk which will provide approximately 200 µg of iodine", 'armGroupLabels': ["Cow's milk"]}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XH', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'University of Surrey', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}