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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05019118
Other study ID # CLUN-20191005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 6, 2021
Est. completion date May 30, 2022

Study information

Verified date August 2021
Source Cooperativas Lacteas Unidas
Contact María Reyes Pérez-Fernández, PhD
Phone 676520946
Email Maria.Reyes.Perez.Fernandez@sergas.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date May 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 65 Years
Eligibility 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 ?-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


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
Spain Nursing University School of Ourense Ourense

Sponsors (2)

Lead Sponsor Collaborator
Cooperativas Lacteas Unidas Galician South Health Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Muñiz-Naveiro O, Domínguez-González R, Bermejo-Barrera A, Cocho de Juan JA, Fraga Bermúdez JM, Goris Pereiras A, López Santamariña A, Martínez Lede I, Valledor Puente J, Fernández-Couto Gómez 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. — View Citation

Roibás L, Martínez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with changes in thyroid function thyroid stimulating hormone blood level 3 months
Secondary HDL level high density lipoproteins blood level 3 months
Secondary selenium selenium blood level 3 months
Secondary IL-6 Interleukina-6 blood level 3 months
Secondary Fecal calprotectin Fecal calprotectin feces level 3 months
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