NCT05949671

Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet

Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet on the Autoimmune System in Patients With Hashimoto's Thyroid

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Acibadem University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Hashimoto's Thyroiditis is an autoimmune disease that attacks thyroid cells through cell- and antibody-mediated immune processes and is characterized by the production of thyroid autoantibodies. In hashimoto, antithyroid peroxidase antibodies are increased and thyroid stimulating hormone levels are elevated. A gluten-free diet regulates thyroid autoimmunization by decreasing the concentration of antibodies. The Mediterranean diet also reduces disease-related oxidative stress parameters in patients with hashimoto's thyroid due to its anti-inflammatory effects. Aims: To evaluate the short-term effects of Mediterranean, gluten-free and Mediterranean gluten-free dietary patterns on thyroid function and autoantibody levels of patients. Study Design: Prospective, single-blind randomized controlled trial including case and control groups Methods: The 40 patients with hashimato thyroiditis included in the study were randomly divided into 4 different groups as gluten-free, Mediterranean, Mediterranean gluten-free and control group for 12 weeks. Thyroid function tests and autoantibody levels were analyzed at the beginning and end of the study. In addition, anthropometric measurements were taken at the beginning and end of the study and food consumption records and food consumption frequencies were evaluated.

Detailed description

The aim of this study was to evaluate the short-term effects of Mediterranean (MD), Gluten Free (GFD) and Mediterranean Gluten Free (MGFD) dietary patterns on the autoimmune system in patients with Hashimoto's Thyroiditis. The study was planned as a prospective single-blind study including case and control groups and 40 women with hashimoto participated. Study participants were not taking medication or supplements to better evaluate the effect of the nutritional intervention on thyroid function. Participants were divided into 4 groups as MD, GFD, MGFD nutrition intervention groups and control group. At the beginning of the study and after three months of nutritional intervention, anthropometric measurements, body composition analysis, thyroid function tests were performed, food consumption records and food consumption frequencies were taken. Weekly menus were planned and the compliance of the individuals with the nutritional intervention applied for three months was evaluated. In this study, the decrease in antibody levels and changes in thyroid function tests were evaluated as short-term effects of the nutritional intervention. Long-term studies evaluating the changes on antibodies with nutritional intervention are needed.

Conditions

• Hashimoto Thyroiditis
• Hashimoto Disease

Interventions

Type	Name	Description
OTHER	mediterranean, gluten-free and mediterranean gluten-free diet intervention	This study is a prospective, single-blind study including case and control groups. Before the study started, participants were informed about the benefits and risks of the study. Participants were randomly divided into four different groups (MD, GFD, MGFD and control group). The intervention groups (MD group (n=10), GFD (n=10), MGFD (n=10)) were administered weekly diets by a dietitian for 12 weeks according to individual-specific and daily energy needs and weight loss was not targeted. Patients in the control group (n=10) did not receive any special dietary intervention. Patients were interviewed weekly to assess adherence to the study protocol and food consumption was recorded at each interview; those who complied with the weekly planned menus by less than eighty percent were excluded from the study.

Timeline

• Start date: 2021-06-10
• Primary completion: 2021-09-10
• Completion: 2022-05-20
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: Turkey (Türkiye)