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

NCT06419309 | Not Yet Recruiting

• 1 other identifier: HUSBFBVDBE001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hashimoto Thyroiditis

Outcome Measures

Primary Outcomes (3)

• Effect of diet on weight loss

  The effect of diets on weight loss will be evaluated. Body composition analyzes of individuals (body weight (kg), body fat ratio (%), body water ratio (%), visceral fat ratio) will be performed using handheld device.

  Start and end of study (8 weeks)

• Effect of diet on hormone level

  The effects of diets on leptin and ghrelin levels will be examined with venous blood samples.

  Start and end of study (8 weeks)

• Effect of diet on inflammatory parameters

  To evaluate oxidative stress parameters, two 5 mL venous blood samples will be taken from each patient in yellow tubes after an overnight fast of at least eight hours between 08:00 and 09:00 in the morning. The blood sample will be kept at room temperature for 10-20 minutes and after being centrifuged at 2000-3000 rpm for 20 minutes, it will be transferred to Eppendorf tubes with the help of a sterile pipette and will be stored in 2 separate refrigerators at -20 °C. IL-6, TNF-alpha, CRP levels will be measured with commercial kits, following the company protocol.

  Start and end of study (8 weeks)

Secondary Outcomes (1)

• Effect of diet on routine hashimoto thyroid parameters

  Start and end of study (8 weeks)

Study Arms (4)

Gluten- lactose free diet

EXPERIMENTAL

People will be given a healthy diet by eliminating gluten-free lactose-containing foods from their diet. It will continue for 8 weeks.

Other: Dietary intervention

Aronia Melanocarpa added and Gluten- lactose free diet

EXPERIMENTAL

In addition to a healthy diet, people will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside) and a gluten-free-lactose-free diet.It will continue for 8 weeks.

Other: Dietary intervention

Aronia Melanocarpa added diet

EXPERIMENTAL

People will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside).It will continue for 8 weeks.

Other: Dietary intervention

Healthy eating group

EXPERIMENTAL

Healthy diet patterns with an average macronutrient content of 10-20% protein, 20-35% fat and 45-60% carbohydrate will be followed for 8 weeks.

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Four different dietary interventions are planned. * Gluten-free, lactose-free diet, * Diet enriched with Aronia Melanocarpa, * Gluten-free, lactose-free and enriched with Aronia Melanocarpa diet, * Healthy diet

Aronia Melanocarpa added and Gluten- lactose free diet; Aronia Melanocarpa added diet; Gluten- lactose free diet; Healthy eating group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Since the prevalence of the disease is high in female individuals, it will be conducted with female individuals.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Halic University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Berrak Basturk, Lecturer

  Halic University

  PRINCIPAL INVESTIGATOR

• Zeynep Ozerson, Assoc. prof.

  Halic University

  STUDY DIRECTOR

• Ayse Kubat Uzum, Profesor

  Istanbul University

  STUDY DIRECTOR

• Melike Cevikdizici, Nurse

  Istanbul University

  STUDY DIRECTOR

• Yusuf Celik, Profesor

  Biruni University

  STUDY DIRECTOR

Central Study Contacts

Berrak Basturk, Lecturer

CONTACT

05465088090; berrakerguden@halic.edu.tr

Ayse Kubat Uzum, Profesor

CONTACT

akubatuzum@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: August 15, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

TU (1)