Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419309
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-14
Brief Title:
Comparison of the Effect of Gluten-Free-Lactose-Free Aronia Melanocarpa Supplemented Diet in Patients With Hashimotos Thyroiditis
Sponsor:
Halic University
Organization:
Halic University
Study Overview
Official Title:
Comparison of the Effect of Gluten-Free-Lactose-Free Aronia Melanocarpa Supplemented Diet on Leptin Ghrelin Levels and Inflammatory Status in Patients With Hashimoto Thyroiditis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hashimotos thyroiditis HT is the most common cause of chronic hypothyroidism in areas with sufficient iodine stemming from an autoimmune response against thyroid peroxidase andor 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 interleukin-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 Hashimotos thyroiditis The study aims to recruit a minimum of 80 participants aged 18-65 years diagnosed with Hashimotos 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 Melanocarpa in the diet high anthocyanin content 6924 mg100 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 thyroid-stimulating hormon free T4 free T3 anti-thyroid peroxidase anti-Tg interleukin-6anti tumor necrosis factor alpha C-reactive protein 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None