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

NCT05949671 | Completed DMC

• 1 other identifier: ACU-BES-SBF-MUTLUTUCEULKER-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mediterranean diet; Mediterranean gluten-free diet; Gluten-free diet; hashimoto

Outcome Measures

Primary Outcomes (1)

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

  Diet group (MD group (n=10)) was administered weekly diets for 12 weeks by a dietitian according to personalised and daily energy needs and weight loss was not targeted.

  May 2021-June2022

Other Outcomes (1)

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

  May 2021-May 2022

Study Arms (4)

Mediterranean groups

EXPERIMENTAL

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)) 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 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.

Other: mediterranean, gluten-free and mediterranean gluten-free diet intervention

Gluten-Free groups

EXPERIMENTAL

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 (GFD (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 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.

Other: mediterranean, gluten-free and mediterranean gluten-free diet intervention

Mediterranean Gluten-Free groups

EXPERIMENTAL

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 (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 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.

Other: mediterranean, gluten-free and mediterranean gluten-free diet intervention

control group

NO INTERVENTION

Patients in the control group (n=10) did not receive any special dietary intervention.

Interventions

mediterranean, gluten-free and mediterranean gluten-free diet intervention OTHER

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.

Gluten-Free groups; Mediterranean Gluten-Free groups; Mediterranean groups

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women with hashimoto's thyroiditis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To apply to the Internal Diseases (Internal Medicine) outpatient clinic, to be diagnosed with hashimato thyroid (HT) by a physician and to be between the ages of 18-65,
• No diagnosis of any autoimmune system disease other than HT that may adversely affect the study,
• No symptoms of celiac disease and no diagnosis,
• Not following a gluten-free diet in the last three months,
• Not being diagnosed with an eating behaviour disorder,
• Not having any communication problems,
• Signing the informed consent form,
• Having had a thyroid ultrasound within the last six months,
• Elevated anti -TPO (\>5.61 IU/ml) and anti Tg (\>4.11 IU/ml),
• To have TSH, Free T3 and Free T4 tests performed,
• Body Mass Index to be in the range of 18.5 kg/m2 - 30 kg/m2 \<,
• Not losing 5% and/or more body weight in the last month

You may not qualify if:

• \- Under 18 years of age and over 65 years of age,
• Having thyroid disease other than HT,
• Having a diagnosis of autoimmune system disease other than HT that may adversely affect the study,
• Symptoms and/or diagnosis of celiac disease,
• To have been diagnosed with non-celiac gluten sensitivity,
• Following a gluten-free diet within the last three months,
• A diet therapy that has an effect on the autoimmune system within the last three months,
• Being diagnosed with eating behaviour disorder,
• Having any communication problems,
• Not signing the informed consent form,
• Failure to adapt to the work during the working period, to be in a situation/behaviour that may adversely affect the work,
• To have applied any nutritional intervention during the last three months prior to the study,
• Being pregnant or breastfeeding,
• Taking supplements such as selenium, zinc, vitamin D and/or iodine, which may affect the course of the study,
• To have received cancer treatment and / or to be receiving cancer treatment,

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Istınye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mutlu Tuçe Ülker, Dr

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients do not know which group they belong to and other groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: doctoral thesis including case and control groups

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: June 10, 2021
• Primary Completion: September 10, 2021
• Study Completion: May 20, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

TU (1)