An interventional study of Gluten-free diet and Gluten capsules supplementation in Autoimmune Thyroiditis, sponsored by Medical University of Gdansk. Completed at 1 site in Poland. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Supportive care
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:
Participants:
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).
Exclusion Criteria:
Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).
Other: Gluten-free diet · Other: Gluten capsules supplementation
Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).
Other: Gluten-free diet · Other: Placebo capsules supplementation
Diet with gluten elimination followed by all participants for 8 weeks
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Change in gut microbiome composition
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Time frame: Baseline (T0) to week 4 (T1)
Change in gut microbiome composition
Bacterial DNA was extracted from stool samples and then 16S rRNA sequencing was conducted to check the change in presence of various bacterial taxa.
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid stimulating hormone (TSH)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid stimulating hormone (TSH)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone thyroxine (FT4)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid hormone thyroxine (FT4)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid hormone triiodothyronine (FT3)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroid peroxidase antibodies (TPOAb)
Time frame: Week 4 (T1) to week 8 (T2)
Change in thyroglobulin antibodies (TgAb)
Time frame: Baseline (T0) to week 4 (T1)
Change in thyroglobulin antibodies (TgAb)
Time frame: Week 4 (T1) to week 8 (T2)
Change in quality of life measured in ThyPROpl questionnaire
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.
Time frame: Baseline (T0) to week 4 (T1)
Change in quality of life measured in ThyPROpl questionnaire
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.
Time frame: Week 4 (T1) to week 8 (T2)
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline (T0) to week 4 (T1)
Change in erythrocyte sedimentation rate (ESR)
Time frame: Week 4 (T1) to week 8 (T2)
Change in C-reactive protein (CRP)
Time frame: Baseline (T0) to week 4 (T1)
Change in C-reactive protein (CRP)
Time frame: Week 4 (T1) to week 8 (T2)
Change in fasting glucose
Time frame: Baseline (T0) to week 4 (T1)
Change in fasting glucose
Time frame: Week 4 (T1) to week 8 (T2)
Plan to share: No
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Medical University of Gdansk