Subclinical Hypothyroidism
Conditions
Keywords
Hypothyroidism, selenium, women
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.
Interventions
OTHERExperimental milk
UNICLA milk naturally enriched in selenium and omega-3.
OTHERExperimental yogur
UNICLA yogur naturally enriched in selenium and omega-3.
OTHERExperimental fresh cheese
UNICLA fresh cheese naturally enriched in selenium and omega-3.
OTHERPlacebo milk
Conventional milk
OTHERPlacebo yogur
Conventional yogur
OTHERPlacebo fresh cheese
Conventional fresh cheese
Sponsors
Galician South Health Research Institute
Cooperativas Lacteas Unidas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The masking process will be triple blind, that is, both the participating women, the research staff (including those in charge of delivering the products and the one who performs and interprets the measurements), as well as the analyst, won't know at any time what group belong to patients. All the products in the study (Únicla dairy) as well as their respective placebos (conventional FEIRACO equivalent products) will maintain a similar format and labeling, with the organoleptic characteristics of dairy products being very similar. Masking will be opened at the time that the last data interpretation of the last subject included was made and before starting the statistical analysis
Intervention model description
Randomized, masked and controlled nutritional intervention study
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with changes in thyroid function | 3 months | thyroid stimulating hormone blood level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL level | 3 months | high density lipoproteins blood level |
| selenium | 3 months | selenium blood level |
| IL-6 | 3 months | Interleukina-6 blood level |
| Fecal calprotectin | 3 months | Fecal calprotectin feces level |
Countries
Spain
Contacts
Primary ContactMaría Reyes Pérez-Fernández, PhD
Backup ContactIsmael Martínez-Lede, graduate
Outcome results
None listed