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

NCT05949671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-18

No results posted yet for this study

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.

Conditions

  • Hashimoto Thyroiditis
  • Hashimoto Disease

Interventions

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.

Sponsors & Collaborators

  • Acibadem University

    lead OTHER

Principal Investigators

  • Mutlu Tuçe Ülker, Dr · Acibadem University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2021-09-10
Completion
2022-05-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949671 on ClinicalTrials.gov