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

Primary Purpose

Hashimoto Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Individually balanced elimination/reducing diets
Individually balanced reducing diets (without elimination)
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hashimoto Disease focused on measuring Hashimoto, Obesity, Elimination diet, Thyroid gland, Adults

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

---

Sites / Locations

  • Department of Dietetic and Clinical Nutrition; Medical University of Bialystok

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test group (group A)

Control group (group B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
February 12, 2021
Sponsor
Medical University of Bialystok
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1. Study Identification

Unique Protocol Identification Number
NCT04752202
Brief Title
The Influence of Reducing Diets on Changes in Thyroid Parameters in Obese Women With Hashimoto's Disease
Official Title
The Influence of Reducing Diets on Changes in Thyroid Parameters in Women Suffering From Obesity and Hashimoto's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hashimoto Disease, Obesity
Keywords
Hashimoto, Obesity, Elimination diet, Thyroid gland, Adults

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group (group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (group B)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individually balanced elimination/reducing diets
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individually balanced reducing diets (without elimination)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
The body weight (kg) was measured using a scale with a stadiometer.
Time Frame
This measurement was repeated during 3 visits every 12 weeks.
Title
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.
Description
The height (cm) was measured using a scale with a stadiometer. This measurement is needed to calculate the Body Mass Index.
Time Frame
This measurement was repeated during 3 visits every 12 weeks.
Title
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.
Description
Body Mass Index (kg/m^2) was calculated from the measurements of height and weight using a mathematical formula.
Time Frame
This measurement was repeated during 3 visits every 12 weeks.
Title
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.
Description
Muscle mass (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Time Frame
This measurement was repeated during 3 visits every 12 weeks.
Title
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.
Description
Total body water (kg) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Time Frame
This measurement was repeated during 3 visits every 12 weeks.
Title
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.
Description
Percent body fat (%) was determined using the bioimpedance method with a TANITA BC-420 body composition analyzer (T6360, Japan).
Time Frame
This measurement was repeated during 3 visits every 12 weeks.
Title
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.
Description
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.
Time Frame
This examination was repeated during 3 visits every 12 weeks.
Title
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.
Description
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.
Time Frame
This examination was repeated during 3 visits every 12 weeks.
Title
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.
Description
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.
Time Frame
This examination was repeated during 3 visits every 12 weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: ---
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucyna Ostrowska, Professor
Organizational Affiliation
Medical University of Bialystok
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dominika Gier, PhD
Organizational Affiliation
Medical University of Bialystok
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dietetic and Clinical Nutrition; Medical University of Bialystok
City
Bialystok
ZIP/Postal Code
15-054
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31681268
Citation
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Results Reference
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23526236
Citation
Rotondi M, Leporati P, Rizza MI, Clerici A, Groppelli G, Pallavicini C, La Manna A, Fonte R, Magri F, Biondi B, Chiovato L. Raised serum TSH in morbid-obese and non-obese patients: effect on the circulating lipid profile. Endocrine. 2014 Feb;45(1):92-7. doi: 10.1007/s12020-013-9928-8. Epub 2013 Mar 23.
Results Reference
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PubMed Identifier
16259889
Citation
Moulin de Moraes CM, Mancini MC, de Melo ME, Figueiredo DA, Villares SM, Rascovski A, Zilberstein B, Halpern A. Prevalence of subclinical hypothyroidism in a morbidly obese population and improvement after weight loss induced by Roux-en-Y gastric bypass. Obes Surg. 2005 Oct;15(9):1287-91. doi: 10.1381/096089205774512537.
Results Reference
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PubMed Identifier
28469599
Citation
Draman MS, Stechman M, Scott-Coombes D, Dayan CM, Rees DA, Ludgate M, Zhang L. The Role of Thyrotropin Receptor Activation in Adipogenesis and Modulation of Fat Phenotype. Front Endocrinol (Lausanne). 2017 Apr 19;8:83. doi: 10.3389/fendo.2017.00083. eCollection 2017.
Results Reference
background
PubMed Identifier
21508145
Citation
Krysiak R, Okopien B. The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2011 Jul;96(7):2206-15. doi: 10.1210/jc.2010-2986. Epub 2011 Apr 20.
Results Reference
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Citation
Carroccio A, D'Alcamo A, Cavataio F, Soresi M, Seidita A, Sciume C, Geraci G, Iacono G, Mansueto P. High Proportions of People With Nonceliac Wheat Sensitivity Have Autoimmune Disease or Antinuclear Antibodies. Gastroenterology. 2015 Sep;149(3):596-603.e1. doi: 10.1053/j.gastro.2015.05.040. Epub 2015 May 27.
Results Reference
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PubMed Identifier
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Citation
Krysiak R, Szkrobka W, Okopien B. The Effect of Gluten-Free Diet on Thyroid Autoimmunity in Drug-Naive Women with Hashimoto's Thyroiditis: A Pilot Study. Exp Clin Endocrinol Diabetes. 2019 Jul;127(7):417-422. doi: 10.1055/a-0653-7108. Epub 2018 Jul 30.
Results Reference
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Citation
Pandit AA, Vijay Warde M, Menon PS. Correlation of number of intrathyroid lymphocytes with antimicrosomal antibody titer in Hashimoto's thyroiditis. Diagn Cytopathol. 2003 Feb;28(2):63-5. doi: 10.1002/dc.10235.
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The Influence of Reducing Diets on Changes in Thyroid Parameters in Obese Women With Hashimoto's Disease

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