- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06419309
Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet in Patients With Hashimoto's Thyroiditis
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Berrak Basturk, Lecturer
- Phone Number: 05465088090
- Email: berrakerguden@halic.edu.tr
Study Contact Backup
- Name: Ayse Kubat Uzum, Profesor
- Email: akubatuzum@yahoo.com
Study Locations
-
-
-
İstanbul, Turkey
- Halic University
-
Contact:
- Berrak Basturk, Lecturer
- Phone Number: +905465088090
- Email: berrakerguden@halic.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant or breastfeeding mother,
- Individuals with chronic diseases,
- Individuals allergic to red fruits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gluten- lactose free diet
People will be given a healthy diet by eliminating gluten-free lactose-containing foods from their diet.
It will continue for 8 weeks.
|
Four different dietary interventions are planned.
|
Experimental: Healthy eating group
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.
|
Four different dietary interventions are planned.
|
Experimental: Aronia Melanocarpa added and Gluten- lactose free diet
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.
|
Four different dietary interventions are planned.
|
Experimental: Aronia Melanocarpa added diet
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.
|
Four different dietary interventions are planned.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Start and end of study (8 weeks)
|
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. |
Start and end of study (8 weeks)
|
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.
|
Start and end of study (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of diet on routine hashimoto thyroid parameters
Time Frame: Start and end of study (8 weeks)
|
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.
|
Start and end of study (8 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Berrak Basturk, Lecturer, Halic University
- Study Director: Zeynep Ozerson, Assoc. prof., Halic University
- Study Director: Ayse Kubat Uzum, Profesor, Istanbul University
- Study Director: Melike Cevikdizici, Nurse, Istanbul University
- Study Director: Yusuf Celik, Profesor, Biruni University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUSBFBVDBE001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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