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Gluten-free Diet in Women With Autoimmune Thyroiditis

NCT06249074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-02-08

No results posted yet for this study

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).

Conditions

  • Autoimmune Thyroiditis

Interventions

OTHER

Gluten-free diet

Diet with gluten elimination followed by all participants for 8 weeks

OTHER

Gluten capsules supplementation

2 g of gluten given in 3 capsules daily for 4 weeks (week 5 to week 8)

OTHER

Placebo capsules supplementation

Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).

Sponsors & Collaborators

  • Nutricia Foundation

    collaborator OTHER

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Aleksandra Rodziewicz, MSc · Medical University of Gdansk

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2021-11-16
Completion
2021-11-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249074 on ClinicalTrials.gov