Dietary Intervention With Únicla Dairy Products (DANTIAN)

Subclinical Hypothyroidism Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05019118
• Other study ID #: CLUN-20191005
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical Hypothyroidism

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

External Links

•   Article preprint magazine Nutrition Hospitalaria