Dietary Intervention With Únicla Dairy Products (DANTIAN)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Subclinical Hypothyroidism

Intervention / Treatment
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* Other: Experimental milk
* Other: Experimental yogur
* Other: Experimental fresh cheese
* Other: Placebo milk
* Other: Placebo yogur
* Other: Placebo fresh cheese


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of subclinical hypothyroidism 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: Thyroid surgery or reception of radioactive iodine in a previous period of 12 months 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, masked and controlled nutritional intervention study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/treatment<br>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 | Other: Experimental milk<br>* UNICLA milk naturally enriched in selenium and omega-3.<br>* Other names: ÚNICLA milk;Other: Experimental yogur<br>* UNICLA yogur naturally enriched in selenium and omega-3.<br>* Other names: ÚNICLA yogur;Other: Experimental fresh cheese<br>* UNICLA fresh cheese naturally enriched in selenium and omega-3.<br>* Other names: ÚNICLA fresh cheese;|
| Placebo Comparator: Conventional milk<br>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 | Other: Placebo milk<br>* Conventional milk<br>* Other names: Conventional milk;Other: Placebo yogur<br>* Conventional yogur<br>* Other names: Conventional yogur;Other: Placebo fresh cheese<br>* Conventional fresh cheese<br>* Other names: Conventional fresh cheese;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with changes in thyroid function | thyroid stimulating hormone blood level | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL level | high density lipoproteins blood level | 3 months | 
| selenium | selenium blood level | 3 months | 
| IL-6 | Interleukina-6 blood level | 3 months | 
| Fecal calprotectin | Fecal calprotectin feces level | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium, Hypothyroidism, women