Hashimoto ThyroiditisAnti-TPO/TGNCT07048821
The Impact of Change of Thyroid Antibodies on Hormone Level and Disease Burden in Patients With Hashimoto's Thyroiditis
A study testing Dietary modification in people with Hashimoto Thyroiditis and Mediterranean Diet, run by Sherihan AboElyazed Mohamed Khalil at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Hashimoto Thyroiditis, Mediterranean Diet
- What is being tested?
- Dietary modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with symptoms of hypothyroidism (hypothyroid/euthyroid)
- Positive anti-thyroid antibodies (anti-TPO/anti-TG).
Who cannot join
- Pregnant or lactating females
- Age below 20 years and above 50 years
- presence of any other medical disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Mediterranean Diet on Patients With Hashimoto 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.
Read the detailed description
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
- Conditions
- Hashimoto Thyroiditis, Mediterranean Diet
- Being tested
- Dietary modification
- Keywords
- Anti-TPO, Anti-TG, Hashimoto Thyroiditis, Mediterranean Diet, ThyPRO questionnaire
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary modificationDietary supplement
Also called Mediterranean diet
3-month dietary plan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Dietary modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the serum level of anti-TPO and Anti-TG antibodies
IU/ml
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
Changes in the serum level of TSH
uIU/ml
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
Changes in the serum level of free T4
ng/dl
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
Changes in the serum level of free T3
pg/ml
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
Secondary outcomes (3)
Symptoms of hypothyroidism
ThyPRO Scale The ThyPRO questionnaire comprises 84 items, divided into 13 multi-item scales. Each item is scored from 0 to 4 on a 5-point Likert scale. The scale score is calculated by taking the mean item score and multiplying it by 25 to transform it to a 0-100 scale.
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
changes in serum level of total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein
mg/dl
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
changes in BMI
kg/m^2
Measured: at day 0 (baseline), then remeasured at day 90 of dietary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start5 May 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hashimoto ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherihan AboElyazed Mohamed Khalil
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Sherihan AboElyazed Mohamed Khalil, Ain Shams University
- Investigators
- Manal Abushady, MD, Study director, faculty of medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048821
- Sponsor's protocol ID
- MS 232/2023
- Acronym
- Anti-TPO/TG
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34027377Watt 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.
PubMed 24783018Watt 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.
PubMed 19797502Danailova 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.
PubMed 35563541Bellastella 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.
PubMed 36235782
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mediterranean Diet on Patients With Hashimoto Thyroiditis
- ClinicalTrials.gov ID
- NCT07048821
- Acronym / sponsor ID
- Anti-TPO/TG / MS 232/2023
- Conditions
- Hashimoto Thyroiditis, Mediterranean Diet
- Keywords
- Anti-TPO, Anti-TG, Hashimoto Thyroiditis, Mediterranean Diet, ThyPRO questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sherihan AboElyazed Mohamed KhalilUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 5 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hashimoto thyroiditis | Experimental | Dietary Supplement: Dietary modificationThe investigators advised patients to follow a modified Mediterranean diet plan with a reduction in goitrogenic foods for 12 weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with symptoms of hypothyroidism (hypothyroid/euthyroid)
- Positive anti-thyroid antibodies (anti-TPO/anti-TG).
Key exclusion criteria (3 listed)
- Pregnant or lactating females
- Age below 20 years and above 50 years
- presence of any other medical disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary modificationAlso: Mediterranean diet3-month dietary plan | Dietary supplement | patients with hashimoto thyroiditis |
Primary outcome
Changes in the serum level of anti-TPO and Anti-TG antibodies
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
IU/ml
Changes in the serum level of TSH
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
uIU/ml
Changes in the serum level of free T4
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
ng/dl
Changes in the serum level of free T3
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
pg/ml
3 secondary outcomes
Symptoms of hypothyroidism
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
changes in serum level of total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
changes in BMI
Time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Results publication: PubMed 34027377Groenewegen 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.
- Results publication: PubMed 24783018Watt 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.
- Results publication: PubMed 19797502Watt 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.
- Results publication: PubMed 35563541Danailova 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.
- Results publication: PubMed 36235782Bellastella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Abushady, MD study director
faculty of medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary modification in people with Hashimoto Thyroiditis and Mediterranean Diet, run by Sherihan AboElyazed Mohamed Khalil at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the serum level of anti-TPO and Anti-TG antibodies (time frame: at day 0 (baseline), then remeasured at day 90 of dietary intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048821, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.