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NOT YET RECRUITING
NCT07879690
NA

Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis

Sponsor: University of Barcelona

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate whether a dietary intervention can improve clinical and immunological outcomes in women with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease. The study will enroll premenopausal women aged 18 to 55 years. The dietary intervention consists of the simultaneous exclusion of three groups of potentially pro-inflammatory dietary components: * Gluten-containing cereals, including wheat, barley, and rye. * Casein, the main protein found in milk and dairy products. * High-glycemic-index carbohydrates, such as refined sugar, white bread, and white rice. The primary objective is to determine whether the dietary intervention reduces serum levels of anti-thyroid peroxidase (anti-TPO) antibodies, which are markers of thyroid autoimmunity. Secondary objectives include evaluating whether the intervention improves: * Fatigue and energy levels. * Mood and emotional well-being. * Gastrointestinal symptoms. * Health-related quality of life. Women following the dietary intervention will be compared with women who continue their habitual diet to assess the effectiveness of the intervention. Group allocation will be based on participants' choice at study enrollment. Participants will: * Follow either the dietary intervention or their usual diet for 12 months while continuing their prescribed medical treatment. * Attend four study visits: at baseline and after 4, 8, and 12 months. * Undergo anthropometric assessments (body weight and waist circumference), blood sampling, stool collection, and a telemedicine consultation with a thyroid specialist at each visit. * Complete brief online questionnaires every month to assess dietary adherence, fatigue, mood, gastrointestinal symptoms, and quality of life.

Official title: Impact of Restrictive Diets Targeting Inflammatory Dietary Components (Gluten, Casein, and High-glycemic-index Carbohydrates) on Inflammatory Markers and Quality of Life in Patients With Autoimmune Thyroiditis

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2027-01

Completion Date

2028-12-31

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

OTHER

Gluten-free, casein-free, low-glycemic-index diet

Participants in the intervention group will follow a dietary protocol consisting of the simultaneous exclusion of gluten-containing cereals (including wheat, barley, rye, spelt, and foods containing gluten), dairy products containing casein (including milk, yogurt, cheese, cream, butter, and related products), and high-glycemic-index carbohydrates (including refined sugar, refined grain products, white rice, and pastries). The dietary intervention will be maintained continuously for 12 months. No investigational medications, mandatory dietary supplements, or other therapeutic interventions will be administered as part of the study protocol.

Locations (1)

Centre de Dietètica Laurence Lestang

Les Escaldes, Escaldes-Engordany, Andorra