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| Name | Class |
|---|---|
| Galician South Health Research Institute | NETWORK |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/treatment | Experimental | 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 |
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| Conventional milk | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental milk | Other | UNICLA milk naturally enriched in selenium and omega-3. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with changes in thyroid function | thyroid stimulating hormone blood level | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HDL level | high density lipoproteins blood level | 3 months |
| selenium | selenium blood level | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Reyes Pérez-Fernández, PhD | Contact | 676520946 | Maria.Reyes.Perez.Fernandez@sergas.es | |
| Ismael Martínez-Lede, graduate | Contact | 0034609563353 | ismael.martinez@clun.es |
| Name | Affiliation | Role |
|---|---|---|
| Maria Reyes Pérez- Fernández, PhD | Galicia sur sanitary research institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nursing University School of Ourense | Ourense | 32005 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27239712 | Background | 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. | |
| 16332137 | Background | 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. |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Randomized, masked and controlled nutritional intervention study
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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
| Experimental yogur | Other | UNICLA yogur naturally enriched in selenium and omega-3. |
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| Experimental fresh cheese | Other | UNICLA fresh cheese naturally enriched in selenium and omega-3. |
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| Placebo milk | Other | Conventional milk |
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| Placebo yogur | Other | Conventional yogur |
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| Placebo fresh cheese | Other | Conventional fresh cheese |
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| IL-6 | Interleukina-6 blood level | 3 months |
| Fecal calprotectin | Fecal calprotectin feces level | 3 months |