Dietary Intervention With Únicla Dairy Products (DANTIAN)

United Dairy Cooperatives (CLUN)

Status: Unknown

Conditions: Subclinical Hypothyroidism

Treatments: Other: Experimental fresh cheese; Other: Placebo fresh cheese; Other: Placebo yogur; Other: Placebo milk; Other: Experimental yogur; Other: Experimental milk

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT05019118

CLUN-20191005

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Intervention/treatment

Experimental group

Description:

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

Treatment:

Other: Experimental milk

Other: Experimental yogur

Other: Experimental fresh cheese

Conventional milk

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo milk

Other: Placebo yogur

Other: Placebo fresh cheese