Dietary Intervention With Únicla Dairy Products (DANTIAN)
NCT ID: NCT05019118
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2021-09-06
2022-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention/treatment
Dairy foods made with UNICLA milk Participants (n = 45) ingested UNICLA milk and dairy products (yogurt and cheese) for three months.
UNICLA 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.
This 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.
Consequently, UNICLA milk and dairy products are naturally enriched in selenium and ω-3 PUFA.
The 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
Experimental milk
UNICLA milk naturally enriched in selenium and omega-3.
Experimental yogur
UNICLA yogur naturally enriched in selenium and omega-3.
Experimental fresh cheese
UNICLA fresh cheese naturally enriched in selenium and omega-3.
Conventional milk
Participants (n = 45) ingest milk and conventional dairy products daily for 3 months.
Daily 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
Placebo milk
Conventional milk
Placebo yogur
Conventional yogur
Placebo fresh cheese
Conventional fresh cheese
Interventions
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Experimental milk
UNICLA milk naturally enriched in selenium and omega-3.
Experimental yogur
UNICLA yogur naturally enriched in selenium and omega-3.
Experimental fresh cheese
UNICLA fresh cheese naturally enriched in selenium and omega-3.
Placebo milk
Conventional milk
Placebo yogur
Conventional yogur
Placebo fresh cheese
Conventional fresh cheese
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* TSH levels between 3 and 10 mIU / L
* Normal levels of free triiodothyronine ( T3) and free thyroxine (T4)
* Without previous or current treatment with levothyroxine
Exclusion Criteria
* History of cardiovascular disease and / or thrombosis
* Established diagnosis or clinical suspicion of kidney or liver failure, chronic infections, blood diseases, type I diabetes and type II diabetes
* Drug treatments that affect thyroid function (corticosteroids, amiodarone, propranolol, lithium)
* Statin treatment and / or hormone replacement therapy
* Adjuvant treatment with trace elements, vitamins or antidepressant and antipsychotic drugs
* Hospitalization for serious illness or elective surgery in the past 4 weeks
* Diseases and / or treatments that affect intestinal absorption (proton pump inhibitors)
* Pregnant, planning to become pregnant or breastfeeding women
* Consumption of ω-3 PUFA type food supplements
* Intolerance and / or allergy to lactose and / or cow's milk proteins
* Any pathology that requires close control, advises against their participation or there is an inability to move independently
* Habitual residence outside the study's influence area
* Participation in another clinical trial with drugs, or in other experimental studies
* Refuse to sign the informed consent
40 Years
65 Years
FEMALE
No
Sponsors
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Galician South Health Research Institute
NETWORK
Cooperativas Lacteas Unidas
INDUSTRY
Responsible Party
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María Reyes Pérez Fernández
PhD Clinical Professor
Principal Investigators
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Maria Reyes Pérez- Fernández, PhD
Role: PRINCIPAL_INVESTIGATOR
Galicia sur sanitary research institute
Locations
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Nursing University School of Ourense
Ourense, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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Other Identifiers
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CLUN-20191005
Identifier Type: -
Identifier Source: org_study_id
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