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| Name | Class |
|---|---|
| Ain Shams University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary modification | Dietary Supplement | 3-month dietary plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in BMI | kg/m^2 | after 3 months of intervention |
| changes in serum level of total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein | mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manal Abushady, MD | faculty of medicine, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospital | Cairo | 002 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34027377 | Result | 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. | |
| 24783018 | Result |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2023 | Jun 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050031 | Hashimoto Disease |
| ID | Term |
|---|---|
| D013967 | Thyroiditis, Autoimmune |
| D013966 | Thyroiditis |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D000095500 | Diet, Plant-Based |
| D004032 | Diet |
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| after 3 months of intervention |
| Symptoms of hypothyroidism | Thypro Scale | after 3 months of intervention |
| 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. |
| 19797502 | 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. |
| 35563541 | 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. |
| 36235782 | 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. |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009747 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |