Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05019118
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2021-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Intervention With Únicla Dairy Products (DANTIAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The masking process will be triple blind, that is, both the participating women, the research staff (including those in charge of delivering the products and the one who performs and interprets the measurements), as well as the analyst, won't know at any time what group belong to patients. All the products in the study (Únicla dairy) as well as their respective placebos (conventional FEIRACO equivalent products) will maintain a similar format and labeling, with the organoleptic characteristics of dairy products being very similar. Masking will be opened at the time that the last data interpretation of the last subject included was made and before starting the statistical analysis"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, masked and controlled nutritional intervention study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2021-08-13', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with changes in thyroid function', 'timeFrame': '3 months', 'description': 'thyroid stimulating hormone blood level'}], 'secondaryOutcomes': [{'measure': 'HDL level', 'timeFrame': '3 months', 'description': 'high density lipoproteins blood level'}, {'measure': 'selenium', 'timeFrame': '3 months', 'description': 'selenium blood level'}, {'measure': 'IL-6', 'timeFrame': '3 months', 'description': 'Interleukina-6 blood level'}, {'measure': 'Fecal calprotectin', 'timeFrame': '3 months', 'description': 'Fecal calprotectin feces level'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothyroidism', 'selenium', 'women'], 'conditions': ['Subclinical Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '27239712', 'type': 'BACKGROUND', 'citation': 'Roibas L, Martinez I, Goris A, Barreiro R, Hospido A. An analysis on how switching to a more balanced and naturally improved milk would affect consumer health and the environment. Sci Total Environ. 2016 Oct 1;566-567:685-697. doi: 10.1016/j.scitotenv.2016.05.141. Epub 2016 May 27.'}, {'pmid': '16332137', 'type': 'BACKGROUND', 'citation': "Muniz-Naveiro O, Dominguez-Gonzalez R, Bermejo-Barrera A, Cocho de Juan JA, Fraga Bermudez JM, Goris Pereiras A, Lopez Santamarina A, Martinez Lede I, Valledor Puente J, Fernandez-Couto Gomez L, Bermejo-Barrera P. Selenium content and distribution in cow's milk supplemented with two dietary selenium sources. J Agric Food Chem. 2005 Dec 14;53(25):9817-22. doi: 10.1021/jf050155w."}], 'seeAlsoLinks': [{'url': 'https://www.google.com/search?q=Efectos+de+la+ingesta+de+l%C3%A1cteos+enriquecidos+de+forma+natural+con+selenio+y+omega-3+en+una+muestra+de+mujeres+postmenop%C3%A1usicas+con+s%C3%ADndrome+metab%C3%B3lico%3A+un+ensayo+cl%C3%ADnico+aleatorizado+triple+ciego+y+controlado+con+placebo&oq=Efectos+de+la+ingesta+de+l%C3%A1cteos+enriquecidos+de+forma+natural+con+selenio+y+omega-3+en+una+muestra+de+mujeres+postmenop%C3%A1usicas+con+s%C3%ADndrome+metab%C3%B3lico%3A+un+ensayo+cl%C3%ADnico+aleatorizado+triple+ciego+y+controlado+con+placebo&aqs=chrome..69i57.5124j0j4&sourceid=chrome&ie=UTF-8', 'label': 'Article preprint magazine Nutrition Hospitalaria'}]}, 'descriptionModule': {'briefSummary': 'Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism', 'detailedDescription': 'To analyze in women diagnosed with subclinical hypothyroidism, the effects of consumption of dairy products rich in selenium and omega-3 on symptoms related to thyroid disease and blood lipid profile, inflammatory response, and fatty acid levels in the red blood cell membrane among others.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of subclinical hypothyroidism\n* TSH levels between 3 and 10 mIU / L\n* Normal levels of free triiodothyronine ( T3) and free thyroxine (T4)\n* Without previous or current treatment with levothyroxine\n\nExclusion Criteria:\n\n* Thyroid surgery or reception of radioactive iodine in a previous period of 12 months\n* History of cardiovascular disease and / or thrombosis\n* Established diagnosis or clinical suspicion of kidney or liver failure, chronic infections, blood diseases, type I diabetes and type II diabetes\n* Drug treatments that affect thyroid function (corticosteroids, amiodarone, propranolol, lithium)\n* Statin treatment and / or hormone replacement therapy\n* Adjuvant treatment with trace elements, vitamins or antidepressant and antipsychotic drugs\n* Hospitalization for serious illness or elective surgery in the past 4 weeks\n* Diseases and / or treatments that affect intestinal absorption (proton pump inhibitors)\n* Pregnant, planning to become pregnant or breastfeeding women\n* Consumption of ω-3 PUFA type food supplements\n* Intolerance and / or allergy to lactose and / or cow's milk proteins\n* Any pathology that requires close control, advises against their participation or there is an inability to move independently\n* Habitual residence outside the study's influence area\n* Participation in another clinical trial with drugs, or in other experimental studies\n* Refuse to sign the informed consent"}, 'identificationModule': {'nctId': 'NCT05019118', 'acronym': 'DANTIAN', 'briefTitle': 'Dietary Intervention With Únicla Dairy Products (DANTIAN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cooperativas Lacteas Unidas'}, 'officialTitle': 'Dietary Intervention With Únicla Dairy Products, Naturally Enriched With Selenium and Omega-3 Fatty Acids, May Improve Thyroid-stimulating Hormone (TSH) Levels in Women With Subclinical Hypothyroidism', 'orgStudyIdInfo': {'id': 'CLUN-20191005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention/treatment', 'description': "Dairy foods made with UNICLA milk Participants (n = 45) ingested UNICLA milk and dairy products (yogurt and cheese) for three months.\n\nUNICLA milk is characterised by an improved nutritional composition, obtained by modifying cow's diet, feeeding the dairy cows with a sufficient and balanced ration, which recreates the fatty acid profile of the spring.\n\nThis ration includes pastures, high-quality forages and, among other components, a significant amount of flax seeds, which constitute a source of unsaturated fatty acids such as omega-3 and selenised yeast, as a source of organic selenium.\n\nConsequently, UNICLA milk and dairy products are naturally enriched in selenium and ω-3 PUFA.\n\nThe daily intake reflects the usual consumption habits, being the recommended amounts of 200 ml of milk and 125 g of yogurt per day and 400g of fresh cheese per week", 'interventionNames': ['Other: Experimental milk', 'Other: Experimental yogur', 'Other: Experimental fresh cheese']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional milk', 'description': 'Participants (n = 45) ingest milk and conventional dairy products daily for 3 months.\n\nDaily intake reflects usual dairy consumption habits in "real life" conditions, without forcing or inducing increased consumption. Therefore, the recommended amounts are 200 ml of milk and 125 g of yogurt per day and 400 g of fresh cheese per week', 'interventionNames': ['Other: Placebo milk', 'Other: Placebo yogur', 'Other: Placebo fresh cheese']}], 'interventions': [{'name': 'Experimental milk', 'type': 'OTHER', 'otherNames': ['ÚNICLA milk'], 'description': 'UNICLA milk naturally enriched in selenium and omega-3.', 'armGroupLabels': ['Intervention/treatment']}, {'name': 'Experimental yogur', 'type': 'OTHER', 'otherNames': ['ÚNICLA yogur'], 'description': 'UNICLA yogur naturally enriched in selenium and omega-3.', 'armGroupLabels': ['Intervention/treatment']}, {'name': 'Experimental fresh cheese', 'type': 'OTHER', 'otherNames': ['ÚNICLA fresh cheese'], 'description': 'UNICLA fresh cheese naturally enriched in selenium and omega-3.', 'armGroupLabels': ['Intervention/treatment']}, {'name': 'Placebo milk', 'type': 'OTHER', 'otherNames': ['Conventional milk'], 'description': 'Conventional milk', 'armGroupLabels': ['Conventional milk']}, {'name': 'Placebo yogur', 'type': 'OTHER', 'otherNames': ['Conventional yogur'], 'description': 'Conventional yogur', 'armGroupLabels': ['Conventional milk']}, {'name': 'Placebo fresh cheese', 'type': 'OTHER', 'otherNames': ['Conventional fresh cheese'], 'description': 'Conventional fresh cheese', 'armGroupLabels': ['Conventional milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'contacts': [{'name': 'María Reyes Pérez-Fernández, PhD', 'role': 'CONTACT', 'email': 'Maria.Reyes.Perez.Fernandez@sergas.es', 'phone': '0034676520946'}, {'name': 'Ismael Martínez Lede, graduate', 'role': 'CONTACT', 'email': 'ismael.martinez@clun.es', 'phone': '0034609563353'}], 'facility': 'Nursing University School of Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}], 'centralContacts': [{'name': 'María Reyes Pérez-Fernández, PhD', 'role': 'CONTACT', 'email': 'Maria.Reyes.Perez.Fernandez@sergas.es', 'phone': '676520946'}, {'name': 'Ismael Martínez-Lede, graduate', 'role': 'CONTACT', 'email': 'ismael.martinez@clun.es', 'phone': '0034609563353'}], 'overallOfficials': [{'name': 'Maria Reyes Pérez- Fernández, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Galicia sur sanitary research institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cooperativas Lacteas Unidas', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Galician South Health Research Institute', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Clinical Professor', 'investigatorFullName': 'María Reyes Pérez Fernández', 'investigatorAffiliation': 'Galician South Health Research Institute'}}}}