Gluten-free Diet in Women With Autoimmune Thyroiditis

NCT06249074 | Completed

• 1 other identifier: RG 4/2020
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Autoimmune Thyroiditis

Keywords

diet; gut microbiome; thyroid; gluten-free diet

Outcome Measures

Primary Outcomes (14)

• Change in gut microbiome composition

  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

  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)

  Baseline (T0) to week 4 (T1)

• Change in thyroid stimulating hormone (TSH)

  Week 4 (T1) to week 8 (T2)

• Change in thyroid hormone thyroxine (FT4)

  Baseline (T0) to week 4 (T1)

• Change in thyroid hormone thyroxine (FT4)

  Week 4 (T1) to week 8 (T2)

• Change in thyroid hormone triiodothyronine (FT3)

  Baseline (T0) to week 4 (T1)

• Change in thyroid hormone triiodothyronine (FT3)

  Week 4 (T1) to week 8 (T2)

• Change in thyroid peroxidase antibodies (TPOAb)

  Baseline (T0) to week 4 (T1)

• Change in thyroid peroxidase antibodies (TPOAb)

  Week 4 (T1) to week 8 (T2)

• Change in thyroglobulin antibodies (TgAb)

  Baseline (T0) to week 4 (T1)

• Change in thyroglobulin antibodies (TgAb)

  Week 4 (T1) to week 8 (T2)

• Change in quality of life measured in ThyPROpl questionnaire

  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

  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 Outcomes (6)

• Change in erythrocyte sedimentation rate (ESR)

  Baseline (T0) to week 4 (T1)

• Change in erythrocyte sedimentation rate (ESR)

  Week 4 (T1) to week 8 (T2)

• Change in C-reactive protein (CRP)

  Baseline (T0) to week 4 (T1)

• Change in C-reactive protein (CRP)

  Week 4 (T1) to week 8 (T2)

• Change in fasting glucose

  Baseline (T0) to week 4 (T1)

Study Arms (2)

Gluten

EXPERIMENTAL

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; Other: Gluten capsules supplementation

Placebo

PLACEBO COMPARATOR

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

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

Interventions

Gluten-free diet OTHER

Diet with gluten elimination followed by all participants for 8 weeks

Gluten; Placebo

Gluten capsules supplementation OTHER

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

Gluten

Placebo capsules supplementation OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Only women were included in the study because they are much more likely to suffer from autoimmune thyroiditis and to ensure more uniform results in the selected age group.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Nutricia Foundation: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, 80-210, Poland

Location

Related Publications (22)

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• Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.

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• Poblocki J, Panka T, Szczuko M, Telesinski A, Syrenicz A. Whether a Gluten-Free Diet Should Be Recommended in Chronic Autoimmune Thyroiditis or Not?-A 12-Month Follow-Up. J Clin Med. 2021 Jul 22;10(15):3240. doi: 10.3390/jcm10153240.

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MeSH Terms

Conditions

Thyroiditis, Autoimmune; Thyroid Diseases

Interventions

Diet, Gluten-Free; Glutens; Dietary Supplements

Condition Hierarchy (Ancestors)

Thyroiditis; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins; Food; Food and Beverages

Study Officials

• Aleksandra Rodziewicz, MSc

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: September 22, 2020
• Primary Completion: November 16, 2021
• Study Completion: November 30, 2021
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)