The Influence of Reducing Diets on Changes in Thyroid Parameters in Obese Women With Hashimoto's Disease

Study Overview
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Brief Summary
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Hashimoto's disease is listed among the most common endocrine causes of obesity. As treatment of obesity in women with Hashimoto's disease is frequently unsuccessful, the aim of this study was to evaluate the effectiveness of two different reducing diets and their influence on changes in thyroid parameters in the female patients. A six-month observational/interventional study was performed on 100 women aged 18-65 years, previously diagnosed with Hashimoto's disease and obesity and receiving L-thyroxine. The women were randomly assigned to the test group (group A, n=50) following elimination/reducing diets, and the control group (group B, n=50) following reducing diets with the same caloric content (without elimination). Anthropometric and thyroid parameters were evaluated at the beginning, after 3 months and after 6 months of treatment.

Official Title
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The Influence of Reducing Diets on Changes in Thyroid Parameters in Women Suffering From Obesity and Hashimoto's Disease

Conditions
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Hashimoto Disease, Obesity

Intervention / Treatment
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* Behavioral: Individually balanced elimination/reducing diets
* Behavioral: Individually balanced reducing diets (without elimination)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Hashimoto's disease BMI over 30 kg/m2 Taking the L-thyroxine, 200 mcg of 1-selenomethionine/day, and 30 mg of zinc gluconate/day throughout the study period Exclusion Criteria: ---

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group (group A)<br>The women were randomly assigned to group A. Test group included 50 women aged 18-65 years with previously diagnosed Hashimoto's disease and obesity. Hashimoto's disease (AITD) was diagnosed by a specialist based on the ultrasound image characteristic of AITD and high levels of anti-thyroid antibodies. | Behavioral: Individually balanced elimination/reducing diets<br>* Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced elimination/reducing diets, in accordance with the previously performed food sensitivity tests for 6 months. Laboratory tests for type III food sensitivity in the IgG1-3 class using the ELISA method were performed in an accredited medical laboratory. Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.<br>|
| Other: Control group (group B)<br>The women were randomly assigned to group B. Control group included 50 women aged 18-65 years with previously diagnosed Hashimoto's disease and obesity. Hashimoto's disease (AITD) was diagnosed by a specialist based on the ultrasound image characteristic of AITD and high levels of anti-thyroid antibodies. | Behavioral: Individually balanced reducing diets (without elimination)<br>* Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced reducing diets (without elimination) for 6 months.Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients from obesity and Hashimoto's disease. | The body weight (kg) was measured using a scale with a stadiometer. | This measurement was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on body weight changes in patients suffering from obesity and Hashimoto's disease. | The height (cm) was measured using a scale with a stadiometer. This measurement is needed to calculate the Body Mass Index. | This measurement was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on Body Mass Index changes in patients suffering from obesity and Hashimoto's disease. | Body Mass Index (kg/m^2) was calculated from the measurements of height and weight using a mathematical formula. | This measurement was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in muscle mass in patients suffering from obesity and Hashimoto's disease. | Muscle mass (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan). | This measurement was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in total body water in patients suffering from obesity and Hashimoto's disease. | Total body water (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan). | This measurement was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in percent body fat in patients suffering from obesity and Hashimoto's disease. | Percent body fat (%) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan). | This measurement was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in thyroid parameters in patients suffering from obesity and Hashimoto's disease. | Laboratory tests were performed to determine the following serum levels: TSH, fT3, fT4, anti-TPO, and anti-TG. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast. | This examination was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in glucose blood level in patients suffering from obesity and Hashimoto's disease. | Laboratory tests were performed to determine glucose blood level. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast. | This examination was repeated during 3 visits every 12 weeks. | 
| Effect of reducing/elimination diets based on IgG1-3 food sensitivity tests and standard balanced reducing diets on changes in lipid profile in patients suffering from obesity and Hashimoto's disease. | Laboratory tests were performed to determine the lipid profile: total cholesterol, high-density lipoprotein (HDL), low-density (LDL) cholesterol and triglycerides. Blood samples were collected in an accredited medical laboratory, in the morning, on an empty stomach after a 12-hour fast. | This examination was repeated during 3 visits every 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hashimoto, Obesity, Elimination diet, Thyroid gland, Adults