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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Percentage of patients with changes in thyroid function
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of patients with changes in thyroid function
时间窗: 3 months
thyroid stimulating hormone blood level
次要结局
- Fecal calprotectin(3 months)
- HDL level(3 months)
- IL-6(3 months)
- selenium(3 months)
研究者
María Reyes Pérez Fernández
PhD Clinical Professor
Galician South Health Research Institute