Gluten-free Diet in Women With Autoimmune Thyroiditis

Not Applicable

Completed

• Conditions: Autoimmune Thyroiditis
• Interventions: Other: Gluten-free diet; Other: Gluten capsules supplementation; Other: Placebo capsules supplementation

• Registration Number: NCT06249074
• Lead Sponsor: Medical University of Gdansk

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Primary Completion: 2021-11-16
• Study Completion: 2021-11-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Gluten-free diet	Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).
Gluten	Gluten capsules supplementation	Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).
Placebo	Placebo capsules supplementation	Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).
Gluten	Gluten-free diet	Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).

Primary Outcome Measures

Name	Time	Method
Change in thyroid stimulating hormone (TSH)	Week 4 (T1) to week 8 (T2)
Change in gut microbiome composition	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)	Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)	Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)	Week 4 (T1) to week 8 (T2)
Change in quality of life measured in ThyPROpl questionnaire	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)	Week 4 (T1) to week 8 (T2)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland