Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet in Patients With Hashimoto's Thyroiditis - Trial NCT06419309

Timeline & Enrollment

Primary Outcome

Effect of diet on weight loss,Effect of diet on hormone level,Effect of diet on inflammatory parameters

Summary

Hashimoto's thyroiditis (HT) is the most common cause of chronic hypothyroidism in areas with
 sufficient iodine, stemming from an autoimmune response against thyroid peroxidase and/or
 thyroglobulin. It is the most prevalent autoimmune thyroid disease and a leading cause of
 overall hypothyroidism. Even when they reach euthyroidism, 82% of treated women with HT still
 have excess body weight, and 35% of them are obese. Thyroid dysfunction can affect the
 function of adipose tissue and lead to metabolic disturbances. Leptin can stimulate
 thyroid-stimulating hormone secretion, while thyroid-stimulating hormone can influence leptin
 release from adipose tissue. Additionally, HT patients often exhibit high levels of
 C-reactive protein and IL-6, suggesting an association between increased thyroid-stimulating
 hormone levels and the inflammatory process, which may contribute to comorbid disease risk in
 individuals with HT. Nutrition can serve as a complementary treatment for HT by affecting
 thyroid functions and having anti-inflammatory properties. Dietary interventions may involve
 eliminating gluten, lactose, or certain food components, or focusing on an anti-inflammatory
 dietary pattern while preventing nutritional deficiencies. Therefore, this study is a
 randomized controlled, single-blind trial designed to evaluate the effects of a gluten-free,
 lactose-free diet and a diet enriched with Aronia Melanocarpa, both individually and in
 combination, as well as healthy dietary protocols, on autoantibody levels, leptin, ghrelin,
 oxidative response, and weight loss in patients with Hashimoto's thyroiditis. The study aims
 to recruit a minimum of 80 participants aged 18-65 years, diagnosed with Hashimoto's
 thyroiditis at Istanbul Medical Faculty Hospital. In the initial face-to-face interview,
 participants will provide sociodemographic information, dietary habits, anthropometric
 measurements, and dietary intake records through a questionnaire. The study involves the
 inclusion of Aronia Melanocorpa in the diet (high anthocyanin content, 69.24 mg/100 ml), a
 gluten-free and lactose-free diet, both interventions being applied together, and the
 application of only healthy nutrition protocols to patients over an 8-week period, with serum
 assessments of TSH, fT4, fT3, anti-TPO, anti-Tg, IL-6, TNF-a, CRP, and leptin-ghrelin levels
 at the beginning and end of the study. The goal is to create recommendations for patients,
 improve their quality of life, and establish sustainable nutritional interventions.

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