An interventional study of Dietary intervention in Hashimoto Thyroiditis, sponsored by Halic University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Halic University · Not applicable, Interventional, and Treatment
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.
90 studies on the registry are indexed under Hashimoto Disease; 26 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 43 interventional studies indexed under Hashimoto Disease.
Browse Hashimoto Disease studies →Halic University is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
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
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 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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Start and end of study (8 weeks)
Effect of diet on routine hashimoto thyroid parameters
Thyroid Stimulating Hormone, free thyroxine, free triiodothyronine, thyroid peroxidase antibodies and anti-thyroglobulin biochemical parameters of the participants will be requested by the doctor with institutional permission and patient approval.
Time frame: Start and end of study (8 weeks)
Start is estimated for May 2024; primary completion for May 2025, 12 months later.
Of 19 interventional studies with no phase under Hashimoto Disease, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 65. This study's planned 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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