Clinical trial NCT06419309: Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet in Patients With Hashimoto's Thyroiditis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hashimoto Thyroiditis
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 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 Melanocarpa 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 thyroid-stimulating hormon, free T4, free T3, anti-thyroid peroxidase, anti-Tg, interleukin-6,anti 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.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Hashimoto's thyroiditis by a doctor,
* Being a female individual between the ages of 18-65,
* Not being diagnosed with any chronic disease that would negatively affect functioning other than Hashimoto's thyroid,
* Not having used selenium and iodine supplements in the last month,
* Individuals should not lose more than 4 kg of weight in the last month,
* Not having been on a strict elimination diet for more than 4 months in the last year,
* Not having applied any nutritional intervention during the last three months before the study.

Exclusion Criteria:

* Pregnant or breastfeeding mother,
* Individuals with chronic diseases,
* Individuals allergic to red fruits

Primary outcomes:
measure: Effect of diet on weight loss
timeFrame: Start and end of study (8 weeks)
measure: Effect of diet on hormone level
timeFrame: Start and end of study (8 weeks)
measure: Effect of diet on inflammatory parameters
timeFrame: Start and end of study (8 weeks)
Secondary outcomes:
measure: Effect of diet on routine hashimoto thyroid parameters
timeFrame: Start and end of study (8 weeks)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Halic University
Study officials:
affiliation: Halic University
name: Berrak Basturk, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Halic University
name: Zeynep Ozerson, Assoc. prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: Ayse Kubat Uzum, Profesor
role: STUDY_DIRECTOR
affiliation: Istanbul University
name: Melike Cevikdizici, Nurse
role: STUDY_DIRECTOR
affiliation: Biruni University
name: Yusuf Celik, Profesor
role: STUDY_DIRECTOR
References: