The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato

Study Overview
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Brief Summary
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The goal of this clinical trial is to investigate The effects of an anti-inflammatory diet with or without curcumin supplementation on anthropometric measurements, concentrations of thyroid hormones, anti-TPO, and systemic inflammation in plasma and NFK-B in peripheral blood mononuclear cells in patients with Hashimoto. The main questions it aims to answer are: Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in anthropometric measurements (weight, body mass index, BMI, waist circumference, waist-to-hip ratio) in patients with Hashimoto's disease? Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in the serum concentration of thyroid hormones (T3, T4, TSH) in patients with Hashimoto's disease? Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the change of Anti-TPO concentration in patients with Hashimoto's disease? Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in systemic inflammation indicators (hs-CRP, IL-6) in plasma and NF-κB in peripheral blood mononuclear cells in patients with Hashimoto's disease?

Official Title
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The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato

Conditions
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Thyroid Diseases, Hypothyroidism, Hashimoto Disease

Intervention / Treatment
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* Dietary Supplement: curcumin
* Behavioral: Anti-inflammatory diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having Hashimoto's thyroiditis Willingness to cooperate Body mass index between 35 and 18.5 TSH less than ten and without clinical symptoms Not taking levothyroxine tablets Exclusion Criteria: Pregnancy and breastfeeding kidney Diseases Follow non-routine weight loss diets for three months before the start of the study × Taking slimming and fat-burning drugs, fiber powder Mineral, vegetable, and fiber vitamin supplements

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects are Hashimoto's patients who, if they wish to participate in this research, a written consent form will be obtained from the patients at the beginning of the study. The patients will be classified according to age and sex. Then, using Stratified Block Randomization, patients will be placed in one of two intervention or placebo groups. The intervention will last 12 weeks, and the anti-inflammatory diet will be personalized based on each person's calorie intake. Patients will be asked to take one tablet with cold water daily (morning, noon, and night with the main meals). Also, the curcumin placebo in size, shape, color, appearance, smell, and dispensing cans of the drug will be similar to the curcumin supplement.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The group receiving anti-inflammatory diet with curcumin supplement<br>Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg curcumin capsules along with the main meals of breakfast, lunch, and dinner. | Dietary Supplement: curcumin<br>* Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner<br>Behavioral: Anti-inflammatory diet<br>* The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.<br>|
| Placebo Comparator: Group receiving anti-inflammatory regimen with curcumin placebo<br>Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg placebo capsules of curcumin (microcrystalline cellulose) and the main meals of breakfast, lunch, and dinner. | Behavioral: Anti-inflammatory diet<br>* The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL6 | Interleukin 6 | 3 month | 
| hs-Crp | high-sensitivity C-reactive protein | 3 month | 
| NF-KB | Nuclear factor kappa-light-chain-enhancer of activated B cells | 3 month | 
| Anti-tpo | antithyroperoxidase | 3 month | 
| T4 | Thyroxine | 3 month | 
| T3 | Triiodothyronine | 3 month | 
| TSH | Thyroid-stimulating hormone | 3 month | 
| waist circumference | waist circumference in Centimeter | 3 month | 
| hip circumference | hip circumference in Centimeter | 3 month | 
| waist to hip ratio | an Anthropometric index | 3 month | 
| BMI | Body Mass Index - Anthropometric index | 3 month | 
| Total Cholestrol | serum lipid profile | 3 month | 
| TG | Triglyceride - serum lipid profile | 3 month | 
| Hb | hemoglobin - Blood test | 3 month | 
| hematocrit | Blood test | 3 month | 
| LDL | low-density lipoprotein | 3 month | 
| HDL | high-density lipoprotein | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid Diseases, Hypothyroidism, Hashimoto Disease, Anti-inflammatory diet, Curcumin