Clinical trial NCT05019118: Dietary Intervention With Únicla Dairy Products (DANTIAN)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subclinical Hypothyroidism
Keywords: Hypothyroidism
selenium
women
Lead sponsor: Cooperativas Lacteas Unidas
Sponsor class: INDUSTRY
Collaborators: name: Galician South Health Research Institute
First posted: 2021-08-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, masked and controlled nutritional intervention study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with changes in thyroid function
timeFrame: 3 months
Secondary outcomes:
measure: HDL level
timeFrame: 3 months
measure: selenium
timeFrame: 3 months
measure: IL-6
timeFrame: 3 months
measure: Fecal calprotectin
timeFrame: 3 months
Other outcomes:
Locations:
city: Ourense
country: Spain
facility: Nursing University School of Ourense
Study officials:
affiliation: Galicia sur sanitary research institute
name: Maria Reyes Pérez- Fernández, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.