Hashimoto ThyroiditisNCT05949671
Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet
A study testing mediterranean, gluten-free and mediterranean gluten-free diet intervention in people with Hashimoto Thyroiditis and Hashimoto Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hashimoto Thyroiditis, Hashimoto Disease
- What is being tested?
- mediterranean, gluten-free and mediterranean gluten-free diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2021to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- - 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,
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- 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,
- Having other endocrine or metabolic diseases (e.g. diabetes, cardiovascular diseases),
- Diagnosed with a disease lasting more than 4 months in the last 12 months and other specialised dietary / compositionally different dietary patterns (e.g. high protein, ketogenic, low energy content < 1000 kcal/day),
- Body Mass Index <18.5 kg/m2 or BMI≥30 kg/m2,
- Loss of 5% and/or more body weight in the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet on the Autoimmune System in Patients With Hashimoto's Thyroid
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.
Read the 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
- Being tested
- mediterranean, gluten-free and mediterranean gluten-free diet intervention
- Keywords
- Mediterranean diet, Mediterranean gluten-free diet, Gluten-free diet, hashimoto
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean, gluten-free and mediterranean gluten-free diet interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: May 2021-June2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start10 Jun 2021
- Primary completion10 Sep 2021
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto ThyroiditisStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- doctoral thesis including case and control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mutlu Tuçe Ülker, Dr, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949671
- Sponsor's protocol ID
- ACU-BES-SBF-MUTLUTUCEULKER-001
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet on the Autoimmune System in Patients With Hashimoto's Thyroid
- ClinicalTrials.gov ID
- NCT05949671
- Acronym / sponsor ID
- ACU-BES-SBF-MUTLUTUCEULKER-001
- Conditions
- Hashimoto Thyroiditis, Hashimoto Disease
- Keywords
- Mediterranean diet, Mediterranean gluten-free diet, Gluten-free diet, hashimoto
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- doctoral thesis including case and control groups
| Arm | Type | Receives |
|---|---|---|
| Mediterranean groups | Experimental | Other: mediterranean, gluten-free and mediterranean gluten-free diet interventionThis 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. |
| Gluten-Free groups | Experimental | Other: mediterranean, gluten-free and mediterranean gluten-free diet interventionThis 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. |
| Mediterranean Gluten-Free groups | Experimental | Other: mediterranean, gluten-free and mediterranean gluten-free diet interventionThis 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. |
| control group | No intervention | –Patients in the control group (n=10) did not receive any special dietary intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (19 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mediterranean, gluten-free and mediterranean gluten-free diet interventionThis 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. | Other | Gluten-Free groups, Mediterranean Gluten-Free groups, Mediterranean groups |
Primary outcome
Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet on the Autoimmune System in Patients with Hashimoto's Thyroid
Time frame: May 2021-June2022
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mutlu Tuçe Ülker, Dr principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean, gluten-free and mediterranean gluten-free diet intervention in people with Hashimoto Thyroiditis and Hashimoto Disease, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Effect of Gluten-Free Diet and Mediterranean Diet on the Autoimmune System in Patients with Hashimoto's Thyroid (time frame: May 2021-June2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.