Clinical trial NCT06249074: Gluten-free Diet in Women With Autoimmune Thyroiditis
Official title: The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Thyroiditis
Keywords: diet
gut microbiome
thyroid
gluten-free diet
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2024-02-08
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in gut microbiome composition
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in gut microbiome composition
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in thyroid stimulating hormone (TSH)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in thyroid stimulating hormone (TSH)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in thyroid hormone thyroxine (FT4)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in thyroid hormone thyroxine (FT4)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in thyroid hormone triiodothyronine (FT3)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in thyroid hormone triiodothyronine (FT3)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in thyroid peroxidase antibodies (TPOAb)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in thyroid peroxidase antibodies (TPOAb)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in thyroglobulin antibodies (TgAb)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in thyroglobulin antibodies (TgAb)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in quality of life measured in ThyPROpl questionnaire
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in quality of life measured in ThyPROpl questionnaire
timeFrame: Week 4 (T1) to week 8 (T2)
Secondary outcomes:
measure: Change in erythrocyte sedimentation rate (ESR)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in erythrocyte sedimentation rate (ESR)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in C-reactive protein (CRP)
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in C-reactive protein (CRP)
timeFrame: Week 4 (T1) to week 8 (T2)
measure: Change in fasting glucose
timeFrame: Baseline (T0) to week 4 (T1)
measure: Change in fasting glucose
timeFrame: Week 4 (T1) to week 8 (T2)
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
Study officials:
affiliation: Medical University of Gdansk
name: Aleksandra Rodziewicz, MSc
role: PRINCIPAL_INVESTIGATOR
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