Gluten-free Diet in Women With Autoimmune Thyroiditis

Medical University of Gdansk

Status: Completed

Conditions: Autoimmune Thyroiditis

Treatments: Other: Gluten-free diet; Other: Placebo capsules supplementation; Other: Gluten capsules supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06249074

RG 4/2020

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Gluten

Experimental group

Description:

Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).

Treatment:

Other: Gluten-free diet

Other: Gluten capsules supplementation

Placebo

Placebo Comparator group

Description:

Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).

Treatment:

Other: Placebo capsules supplementation

Other: Gluten-free diet