Hashimoto ThyroiditisNCT06419309
Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet in Patients With Hashimoto's Thyroiditis
A study testing Dietary intervention in people with Hashimoto Thyroiditis, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Hashimoto's thyroiditis (HT) is the most common cause of chronic hypothyroidism in areas with sufficient iodine, stemming from an autoimmune response against thyroid peroxidase and/or thyroglobulin. It is the most prevalent autoimmune thyroid disease and a leading cause of overall hypothyroidism. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hashimoto Thyroiditis
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Aug 2025
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with Hashimoto's thyroiditis by a doctor,
- Being a female individual between the ages of 18-65,
- Not being diagnosed with any chronic disease that would negatively affect functioning other than Hashimoto's thyroid,
- Not having used selenium and iodine supplements in the last month,
- Individuals should not lose more than 4 kg of weight in the last month,
- Not having been on a strict elimination diet for more than 4 months in the last year,
- Not having applied any nutritional intervention during the last three months before the study.
Who cannot join
- Pregnant or breastfeeding mother,
- Individuals with chronic diseases,
- Individuals allergic to red fruits
Trial locations and contacts
1 site in 1 country.
Ayse Kubat Uzum, Profesor contact
Turkey (Türkiye)1 site
Halic University
Istanbul
Berrak Basturk, Lecturer, +905465088090, berrakerguden@halic.edu.tr
About this study
Official title: Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet on Leptin, Ghrelin Levels and Inflammatory Status in Patients With Hashimoto Thyroiditis
Hashimoto's thyroiditis (HT) is the most common cause of chronic hypothyroidism in areas with sufficient iodine, stemming from an autoimmune response against thyroid peroxidase and/or thyroglobulin. It is the most prevalent autoimmune thyroid disease and a leading cause of overall hypothyroidism. Even when they reach euthyroidism, 82% of treated women with HT still have excess body weight, and 35% of them are obese. Thyroid dysfunction can affect the function of adipose tissue and lead to metabolic disturbances. Leptin can stimulate thyroid-stimulating hormone secretion, while thyroid-stimulating hormone can influence leptin release from adipose tissue. Additionally, HT patients often exhibit high levels of C-reactive protein and interleukin-6, suggesting an association between increased thyroid-stimulating hormone levels and the inflammatory process, which may contribute to comorbid disease risk in individuals with HT. Nutrition can serve as a complementary treatment for HT by affecting thyroid functions and having anti-inflammatory properties. Dietary interventions may involve eliminating gluten, lactose, or certain food components, or focusing on an anti-inflammatory dietary pattern while preventing nutritional deficiencies. Therefore, this study is a randomized controlled, single-blind trial designed to evaluate the effects of a gluten-free, lactose-free diet and a diet enriched with Aronia Melanocarpa, both individually and in combination, as well as healthy dietary protocols, on autoantibody levels, leptin, ghrelin, oxidative response, and weight loss in patients with Hashimoto's thyroiditis. The study aims to recruit a minimum of 80 participants aged 18-65 years, diagnosed with Hashimoto's thyroiditis at Istanbul Medical Faculty Hospital. In the initial face-to-face interview, participants will provide sociodemographic information, dietary habits, anthropometric measurements, and dietary intake records through a questionnaire. The study involves the inclusion of Aronia Melanocarpa in the diet (high anthocyanin content, 69.24 mg/100 ml), a gluten-free and lactose-free diet, both interventions being applied together, and the application of only healthy nutrition protocols to patients over an 8-week period, with serum assessments of thyroid-stimulating hormon, free T4, free T3, anti-thyroid peroxidase, anti-Tg, interleukin-6,anti tumor necrosis factor alpha, C-reactive protein and leptin-ghrelin levels at the beginning and end of the study. The goal is to create recommendations for patients, improve their quality of life, and establish sustainable nutritional interventions.
- Conditions
- Hashimoto Thyroiditis
- Being tested
- Dietary intervention
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Four different dietary interventions are planned.
- Gluten-free, lactose-free diet,
- Diet enriched with Aronia Melanocarpa,
- Gluten-free, lactose-free and enriched with Aronia Melanocarpa diet,
- Healthy diet
| Study group | Role | What they receive |
|---|---|---|
| Gluten- lactose free diet | Experimental | People will be given a healthy diet by eliminating gluten-free lactose-containing foods from their diet. It will continue for 8 weeks. Receives: Other: Dietary intervention |
| Aronia Melanocarpa added and Gluten- lactose free diet | Experimental | In addition to a healthy diet, people will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside) and a gluten-free-lactose-free diet.It will continue for 8 weeks. Receives: Other: Dietary intervention |
| Aronia Melanocarpa added diet | Experimental | People will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside).It will continue for 8 weeks. Receives: Other: Dietary intervention |
| Healthy eating group | Experimental | Healthy diet patterns with an average macronutrient content of 10-20% protein, 20-35% fat and 45-60% carbohydrate will be followed for 8 weeks. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of diet on weight loss
The effect of diets on weight loss will be evaluated. Body composition analyzes of individuals (body weight (kg), body fat ratio (%), body water ratio (%), visceral fat ratio) will be performed using handheld device.
Measured: Start and end of study (8 weeks)
Effect of diet on hormone level
The effects of diets on leptin and ghrelin levels will be examined with venous blood samples.
Measured: Start and end of study (8 weeks)
Effect of diet on inflammatory parameters
To evaluate oxidative stress parameters, two 5 mL venous blood samples will be taken from each patient in yellow tubes after an overnight fast of at least eight hours between 08:00 and 09:00 in the morning.
The blood sample will be kept at room temperature for 10-20 minutes and after being centrifuged at 2000-3000 rpm for 20 minutes, it will be transferred to Eppendorf tubes with the help of a sterile pipette and will be stored in 2 separate refrigerators at -20 °C.
IL-6, TNF-alpha, CRP levels will be measured with commercial kits, following the company protocol.
Measured: Start and end of study (8 weeks)
Secondary outcomes (1)
Effect of diet on routine hashimoto thyroid parameters
Thyroid Stimulating Hormone, free thyroxine, free triiodothyronine, thyroid peroxidase antibodies and anti-thyroglobulin biochemical parameters of the participants will be requested by the doctor with institutional permission and patient approval.
Measured: Start and end of study (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berrak Basturk, Lecturer, Principal investigator, Halic UniversityZeynep Ozerson, Assoc. prof., Study director, Halic UniversityAyse Kubat Uzum, Profesor, Study director, Istanbul UniversityMelike Cevikdizici, Nurse, Study director, Istanbul UniversityYusuf Celik, Profesor, Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419309
- Sponsor's protocol ID
- HUSBFBVDBE001
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet on Leptin, Ghrelin Levels and Inflammatory Status in Patients With Hashimoto Thyroiditis
- ClinicalTrials.gov ID
- NCT06419309
- Acronym / sponsor ID
- HUSBFBVDBE001
- Conditions
- Hashimoto Thyroiditis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 17 May 2024 (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.
Hashimoto's thyroiditis (HT) is the most common cause of chronic hypothyroidism in areas with sufficient iodine, stemming from an autoimmune response against thyroid peroxidase and/or thyroglobulin. It is the most prevalent autoimmune thyroid disease and a leading cause of overall hypothyroidism. Even when they reach euthyroidism, 82% of treated women with HT still have excess body weight, and 35% of them are obese. Thyroid dysfunction can affect the function of adipose tissue and lead to metabolic disturbances. Leptin can stimulate thyroid-stimulating hormone secretion, while thyroid-stimulating hormone can influence leptin release from adipose tissue. Additionally, HT patients often exhibit high levels of C-reactive protein and interleukin-6, suggesting an association between increased thyroid-stimulating hormone levels and the inflammatory process, which may contribute to comorbid disease risk in individuals with HT. Nutrition can serve as a complementary treatment for HT by affecting thyroid functions and having anti-inflammatory properties. Dietary interventions may involve eliminating gluten, lactose, or certain food components, or focusing on an anti-inflammatory dietary pattern while preventing nutritional deficiencies. Therefore, this study is a randomized controlled, single-blind trial designed to evaluate the effects of a gluten-free, lactose-free diet and a diet enriched with Aronia Melanocarpa, both individually and in combination, as well as healthy dietary protocols, on autoantibody levels, leptin, ghrelin, oxidative response, and weight loss in patients with Hashimoto's thyroiditis. The study aims to recruit a minimum of 80 participants aged 18-65 years, diagnosed with Hashimoto's thyroiditis at Istanbul Medical Faculty Hospital. In the initial face-to-face interview, participants will provide sociodemographic information, dietary habits, anthropometric measurements, and dietary intake records through a questionnaire. The study involves the inclusion of Aronia Melanocarpa in the diet (high anthocyanin content, 69.24 mg/100 ml), a gluten-free and lactose-free diet, both interventions being applied together, and the application of only healthy nutrition protocols to patients over an 8-week period, with serum assessments of thyroid-stimulating hormon, free T4, free T3, anti-thyroid peroxidase, anti-Tg, interleukin-6,anti tumor necrosis factor alpha, C-reactive protein and leptin-ghrelin levels at the beginning and end of the study. The goal is to create recommendations for patients, improve their quality of life, and establish sustainable nutritional interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gluten- lactose free diet | Experimental | Other: Dietary interventionPeople will be given a healthy diet by eliminating gluten-free lactose-containing foods from their diet. It will continue for 8 weeks. |
| Aronia Melanocarpa added and Gluten- lactose free diet | Experimental | Other: Dietary interventionIn addition to a healthy diet, people will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside) and a gluten-free-lactose-free diet.It will continue for 8 weeks. |
| Aronia Melanocarpa added diet | Experimental | Other: Dietary interventionPeople will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside).It will continue for 8 weeks. |
| Healthy eating group | Experimental | Other: Dietary interventionHealthy diet patterns with an average macronutrient content of 10-20% protein, 20-35% fat and 45-60% carbohydrate will be followed for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being diagnosed with Hashimoto's thyroiditis by a doctor,
- Being a female individual between the ages of 18-65,
- Not being diagnosed with any chronic disease that would negatively affect functioning other than Hashimoto's thyroid,
- Not having used selenium and iodine supplements in the last month,
- Individuals should not lose more than 4 kg of weight in the last month,
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding mother,
- Individuals with chronic diseases,
- Individuals allergic to red fruits
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 |
|---|---|---|
| Dietary interventionFour different dietary interventions are planned. * Gluten-free, lactose-free diet, * Diet enriched with Aronia Melanocarpa, * Gluten-free, lactose-free and enriched with Aronia Melanocarpa diet, * Healthy diet | Other | Aronia Melanocarpa added and Gluten- lactose free diet, Aronia Melanocarpa added diet, Gluten- lactose free diet, Healthy eating group |
Primary outcome
Effect of diet on weight loss
Time frame: Start and end of study (8 weeks)
The effect of diets on weight loss will be evaluated. Body composition analyzes of individuals (body weight (kg), body fat ratio (%), body water ratio (%), visceral fat ratio) will be performed using handheld device.
Effect of diet on hormone level
Time frame: Start and end of study (8 weeks)
The effects of diets on leptin and ghrelin levels will be examined with venous blood samples.
Effect of diet on inflammatory parameters
Time frame: Start and end of study (8 weeks)
To evaluate oxidative stress parameters, two 5 mL venous blood samples will be taken from each patient in yellow tubes after an overnight fast of at least eight hours between 08:00 and 09:00 in the morning. The blood sample will be kept at room temperature for 10-20 minutes and after being centrifuged at 2000-3000 rpm for 20 minutes, it will be transferred to Eppendorf tubes with the help of a sterile pipette and will be stored in 2 separate refrigerators at -20 °C. IL-6, TNF-alpha, CRP levels will be measured with commercial kits, following the company protocol.
1 secondary outcome
Effect of diet on routine hashimoto thyroid parameters
Time frame: Start and end of study (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Ayse Kubat Uzum, Profesor contact
Berrak Basturk, Lecturer principal investigator
Halic University
Zeynep Ozerson, Assoc. prof. study director
Halic University
Ayse Kubat Uzum, Profesor study director
Istanbul 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 Dietary intervention in people with Hashimoto Thyroiditis, run by Halic 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berrak Basturk, Lecturer (05465088090, berrakerguden@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of diet on weight loss (time frame: Start and end of study (8 weeks)). The study lists 3 primary outcomes in all. 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 21 May 2024.