Autoimmune Thyroiditis
Conditions
Keywords
diet, gut microbiome, thyroid, gluten-free diet
Brief summary
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).
Interventions
OTHERGluten-free diet
Diet with gluten elimination followed by all participants for 8 weeks
OTHERGluten capsules supplementation
2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)
OTHERPlacebo capsules supplementation
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).
Sponsors
Nutricia Foundation
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
All participants followed normocaloric gluten-free diet for 8 weeks. After first 4 weeks participants 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).
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life measured in ThyPROpl questionnaire | Baseline (T0) to week 4 (T1) | 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 thyroid hormone thyroxine (FT4) | Baseline (T0) to week 4 (T1) | — |
| Change in thyroid hormone triiodothyronine (FT3) | Baseline (T0) to week 4 (T1) | — |
| Change in thyroid peroxidase antibodies (TPOAb) | Baseline (T0) to week 4 (T1) | — |
| Change in thyroglobulin antibodies (TgAb) | Baseline (T0) to week 4 (T1) | — |
| Change in gut microbiome composition | Baseline (T0) to week 4 (T1) | 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 stimulating hormone (TSH) | Baseline (T0) to week 4 (T1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in C-reactive protein (CRP) | Baseline (T0) to week 4 (T1) |
| Change in fasting glucose | Baseline (T0) to week 4 (T1) |
| Change in erythrocyte sedimentation rate (ESR) | Baseline (T0) to week 4 (T1) |
Countries
Poland
Outcome results
None listed