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

NCT07048821 | Completed DMC

• 1 other identifier: MS 232/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hashimoto Thyroiditis; Mediterranean Diet

Keywords

Anti-TPO; Anti-TG; Hashimoto Thyroiditis; Mediterranean Diet; ThyPRO questionnaire

Outcome Measures

Primary Outcomes (4)

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

  IU/ml

  after 3 months of dietary modification

• Changes in the serum level of TSH

  uIU/ml

  after 3 months of dietary modification

• Changes in the serum level of free T3

  pg/ml

  after 3 months of dietary modification

• Changes in the serum level of free T4

  ng/dl

  after 3 months of dietary modification

Secondary Outcomes (3)

• changes in BMI

  after 3 months of intervention

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

  after 3 months of intervention

• Symptoms of hypothyroidism

  after 3 months of intervention

Study Arms (1)

patients with hashimoto thyroiditis

EXPERIMENTAL

The investigators advised patients to follow a modified Mediterranean diet plan with a reduction in goitrogenic foods for 12 weeks.

Dietary Supplement: Dietary modification

Interventions

Dietary modification DIETARY_SUPPLEMENT

3-month dietary plan

Also known as: Mediterranean diet

patients with hashimoto thyroiditis

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sherihan AboElyazed Mohamed Khalil: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University hospital

Cairo, 002, Egypt

Location

Related Publications (5)

• Groenewegen KL, Mooij CF, van Trotsenburg ASP. Persisting symptoms in patients with Hashimoto's disease despite normal thyroid hormone levels: Does thyroid autoimmunity play a role? A systematic review. J Transl Autoimmun. 2021 Apr 15;4:100101. doi: 10.1016/j.jtauto.2021.100101. eCollection 2021.

  PMID: 34027377 RESULT

• Watt T, Hegedus L, Bjorner JB, Groenvold M, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U. Is Thyroid Autoimmunity per se a Determinant of Quality of Life in Patients with Autoimmune Hypothyroidism? Eur Thyroid J. 2012 Oct;1(3):186-92. doi: 10.1159/000342623. Epub 2012 Sep 29.

  PMID: 24783018 RESULT

• Watt T, Hegedus L, Groenvold M, Bjorner JB, Rasmussen AK, Bonnema SJ, Feldt-Rasmussen U. Validity and reliability of the novel thyroid-specific quality of life questionnaire, ThyPRO. Eur J Endocrinol. 2010 Jan;162(1):161-7. doi: 10.1530/EJE-09-0521. Epub 2009 Oct 1.

  PMID: 19797502 RESULT

• Danailova Y, Velikova T, Nikolaev G, Mitova Z, Shinkov A, Gagov H, Konakchieva R. Nutritional Management of Thyroiditis of Hashimoto. Int J Mol Sci. 2022 May 5;23(9):5144. doi: 10.3390/ijms23095144.

  PMID: 35563541 RESULT

• Bellastella G, Scappaticcio L, Caiazzo F, Tomasuolo M, Carotenuto R, Caputo M, Arena S, Caruso P, Maiorino MI, Esposito K. Mediterranean Diet and Thyroid: An Interesting Alliance. Nutrients. 2022 Oct 4;14(19):4130. doi: 10.3390/nu14194130.

  PMID: 36235782 RESULT

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Diet Therapy; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Diet, Plant-Based; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Manal Abushady, MD

  faculty of medicine, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Endocrinology and Internal Medicine Faculty of Medicine, Ain Shams University Cairo, Egypt

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 2, 2025
• Study Start: May 5, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)