Gluten-free Diet in Women With Autoimmune Thyroiditis

January 31, 2024 updated by: Medical University of Gdansk

The Impact of Gluten-free Diet on the Thyroid Function, Quality of Life and Gut Microbiome Composition in Women With Autoimmune Thyroiditis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-210
        • Medical University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten
Gluten group received gluten in gastrosoluble capsules - 2 g of gluten in 3 capsules daily for 4 weeks (week 5 to week 8).
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)
Placebo Comparator: Placebo
Placebo group received rice starch in gastrosoluble capsules - 3 capsules daily for 4 weeks (week 5 to week 8).
Other: Gluten-free diet
Diet with gluten elimination followed by all participants for 8 weeks
Other: Placebo capsules supplementation
Rice starch in gastrosoluble capsules given in 3 capsules daily for 4 weeks (week 5 to week 8).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut microbiome composition
Time Frame: 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.
Baseline (T0) to week 4 (T1)
Change in gut microbiome composition
Time Frame: 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.
Week 4 (T1) to week 8 (T2)
Change in thyroid stimulating hormone (TSH)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in thyroid stimulating hormone (TSH)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in thyroid hormone thyroxine (FT4)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in thyroid hormone thyroxine (FT4)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in thyroid hormone triiodothyronine (FT3)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in thyroid hormone triiodothyronine (FT3)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in thyroid peroxidase antibodies (TPOAb)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in thyroid peroxidase antibodies (TPOAb)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in thyroglobulin antibodies (TgAb)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in thyroglobulin antibodies (TgAb)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in quality of life measured in ThyPROpl questionnaire
Time Frame: 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.
Baseline (T0) to week 4 (T1)
Change in quality of life measured in ThyPROpl questionnaire
Time Frame: 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.
Week 4 (T1) to week 8 (T2)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in erythrocyte sedimentation rate (ESR)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in erythrocyte sedimentation rate (ESR)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in C-reactive protein (CRP)
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in C-reactive protein (CRP)
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)
Change in fasting glucose
Time Frame: Baseline (T0) to week 4 (T1)
Baseline (T0) to week 4 (T1)
Change in fasting glucose
Time Frame: Week 4 (T1) to week 8 (T2)
Week 4 (T1) to week 8 (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Collaborators

Nutricia Foundation

Investigators

  • Principal Investigator: Aleksandra Rodziewicz, MSc, Medical University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

November 16, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG 4/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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