The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in thyroid stimulating hormone (TSH)
研究概览
简要总结
The purpose of this interventional study was to check if the elimination of gluten from the diet of women with autoimmune thyroiditis affects their health and thyroid function, quality of life, and the gut microbiome composition.
The main questions it aimed to answer were:
- Does the gluten-free diet worsen the gut microbiome composition?
- Does the gluten-free diet improve thyroid function, measured as thyroid stimulating hormone (TSH), thyroid hormones thyroxine (FT4) and triiodothyronine (FT3), thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb)?
- Does the gluten-free diet improve the quality of life?
Participants:
- followed normocaloric gluten-free diet for 8 weeks
- after first 4 weeks were randomly assigned to one of two groups. One group over next 4 weeks additionally to gluten-free diet received gluten in gastrosoluble capsules and second group - rice starch (placebo).
Blood and stool samples were collected before diet (T0), after 4 weeks (T1) and after 8 weeks of diet (T2) (total of 3 samples per participant). Also each participant completed the ThyPROpl quality of life assessment questionnaire for patients with thyroid diseases in three time points: before the diet (T0), after 4 weeks (T1) and after 8 weeks of the diet (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •autoimmune thyroiditis diagnosed by endocrinologist based on increased TPOAb and/or TgAb levels;
- •stabilized thyroid function, i.e. thyroid hormones within normal range;
- •BMI indicating correct body mass, i.e. within 18.5 - 24.9 kg/m^2.
排除标准
- •newly diagnosed autoimmune thyroiditis and unregulated thyroid hormones (hypothyroidism or hyperthyroidism);
- •concomitant celiac disease and / or wheat allergy;
- •gluten-free diet followed during 6 months prior to enrollment;
- •intestinal disorders;
- •antibiotic or probiotic therapy during 6 months prior to enrollment.
结局指标
主要结局
Change in thyroid stimulating hormone (TSH)
时间窗: Week 4 (T1) to week 8 (T2)
Change in gut microbiome composition
时间窗: Week 4 (T1) to week 8 (T2)
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Change in thyroid hormone thyroxine (FT4)
时间窗: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)
时间窗: Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)
时间窗: Week 4 (T1) to week 8 (T2)
Change in quality of life measured in ThyPROpl questionnaire
时间窗: Week 4 (T1) to week 8 (T2)
ThyPROpl is a linguistically validated version of the original ThyPRO questionnaire. ThyPRO is recommended for the assessment of health-related quality of life in patients with benign thyroid disease. ThyPRO consists of 85 questions summarised in 13 scales measuring aspects of QoL relevant to thyroid patients. Patients are asked to rate their responses for each item on a five-point Likert scale: 0 - not at all; 1 - a little; 2 - some; 3 - quite a bit; 4 - very much. Higher scores mean an improvement in the quality of life.
Change in thyroglobulin antibodies (TgAb)
时间窗: Week 4 (T1) to week 8 (T2)
次要结局
- Change in C-reactive protein (CRP)(Week 4 (T1) to week 8 (T2))
- Change in erythrocyte sedimentation rate (ESR)(Week 4 (T1) to week 8 (T2))
- Change in fasting glucose(Week 4 (T1) to week 8 (T2))