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Completed

NCT Number: NCT07048821

The Impact of Change of Thyroid Antibodies on Hormone Level and Disease Burden in Patients With Hashimoto's Thyroiditis

Hashimoto's thyroiditis (HT) is an autoimmune disease affecting the thyroid gland and is one of the most common causes of hypothyroidism. Eating habits may affect the risk of several inflammatory and immune diseases, such as HT. The current knowledge of the diet in HT is insufficient. The Mediterranean diet (MD) is an anti-inflammatory diet characterized by frequent consumption of olive oil, unrefined cereals, fresh or dried fruit and vegetables, moderate amounts of fish, dairy, and meat, and many condiments and spices. It is rich in nutrients and bioactives, which have the potential to offer anti-inflammatory aspects.

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Key information

Conditions

Hashimoto Thyroiditis Autoimmune Diseases Endocrine System Diseases Hashimoto Disease Immune System Diseases Mediterranean Diet Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University hospital

Cairo, 002, Egypt

About this study

The investigators aimed to assess the impact of the Mediterranean diet on patients with Hashimoto thyroiditis using the following outcomes:

Primary outcomes: Anti-TPO antibodies, Anti-Thyroglobulin antibodies, TSH, T3, T4 Secondary outcomes: BMI, Lipid profile, Symptoms of hypothyroidism

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptoms of hypothyroidism (hypothyroid/euthyroid)
  • Positive anti-thyroid antibodies (anti-TPO/anti-TG).

Exclusion criteria

  • Pregnant or lactating females
  • Age below 20 years and above 50 years
  • presence of any other medical disorder

Treatment and study plan

Dietary modification

Dietary Supplement

3-month dietary plan

Other names: Mediterranean diet

Primary outcomes

  1. Changes in the serum level of anti-TPO and Anti-TG antibodies

    Time frame: after 3 months of dietary modification

    IU/ml

  2. Changes in the serum level of TSH

    Time frame: after 3 months of dietary modification

    uIU/ml

  3. Changes in the serum level of free T3

    Time frame: after 3 months of dietary modification

    pg/ml

  4. Changes in the serum level of free T4

    Time frame: after 3 months of dietary modification

    ng/dl

Secondary outcomes

  1. changes in BMI

    Time frame: after 3 months of intervention

    kg/m^2

  2. changes in serum level of total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein

    Time frame: after 3 months of intervention

    mg/dl

  3. Symptoms of hypothyroidism

    Time frame: after 3 months of intervention

    Thypro Scale

Sponsors and collaborators

Lead sponsor

Sherihan AboElyazed Mohamed Khalil

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

The Impact of Mediterranean Diet on Patients With Hashimoto Thyroiditis

Acronym: Anti-TPO/TG

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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