Dietary Intervention With Únicla Dairy Products (DANTIAN)

Not Applicable

• Conditions: Subclinical Hypothyroidism
• Interventions: Other: Experimental milk; Other: Placebo milk; Other: Experimental yogur; Other: Placebo yogur; Other: Experimental fresh cheese; Other: Placebo fresh cheese

• Registration Number: NCT05019118
• Lead Sponsor: Cooperativas Lacteas Unidas

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24
• Study Start: 2021-09-06
• Primary Completion: 2021-12-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention/treatment	Experimental fresh cheese	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
Intervention/treatment	Experimental milk	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
Conventional milk	Placebo fresh cheese	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
Intervention/treatment	Experimental yogur	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
Conventional milk	Placebo 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
Conventional milk	Placebo yogur	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

Primary Outcome Measures

Name	Time	Method
Percentage of patients with changes in thyroid function	3 months	thyroid stimulating hormone blood level

Secondary Outcome Measures

Name	Time	Method
selenium	3 months	selenium blood level
Fecal calprotectin	3 months	Fecal calprotectin feces level
HDL level	3 months	high density lipoproteins blood level
IL-6	3 months	Interleukina-6 blood level

Trial Locations

Locations (1)

Nursing University School of Ourense; 🇪🇸 Ourense, Spain