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

NCT04752202 | Completed

• 1 other identifier: R-I-002/187/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hashimoto Disease; Obesity

Keywords

Hashimoto; Obesity; Elimination diet; Thyroid gland; Adults

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (2)

Test group (group A)

EXPERIMENTAL

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

Control group (group B)

OTHER

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)

Interventions

Individually balanced elimination/reducing diets BEHAVIORAL

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.

Test group (group A)

Individually balanced reducing diets (without elimination) BEHAVIORAL

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.

Control group (group B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Department of Dietetic and Clinical Nutrition; Medical University of Bialystok

Bialystok, 15-054, Poland

Location

Related Publications (8)

• Song RH, Wang B, Yao QM, Li Q, Jia X, Zhang JA. The Impact of Obesity on Thyroid Autoimmunity and Dysfunction: A Systematic Review and Meta-Analysis. Front Immunol. 2019 Oct 1;10:2349. doi: 10.3389/fimmu.2019.02349. eCollection 2019.

  PMID: 31681268 BACKGROUND

• 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.

  PMID: 23526236 BACKGROUND

• 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.

  PMID: 16259889 BACKGROUND

• 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.

  PMID: 28469599 BACKGROUND

• 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.

  PMID: 21508145 BACKGROUND

• 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.

  PMID: 26026392 BACKGROUND

• 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.

  PMID: 30060266 BACKGROUND

• 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.

  PMID: 12561021 BACKGROUND

MeSH Terms

Conditions

Hashimoto Disease; Obesity; Thyroid Diseases

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lucyna Ostrowska, Professor

  Medical University of Bialystok

  STUDY DIRECTOR

• Dominika Gier, PhD

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: March 29, 2019
• Primary Completion: April 19, 2019
• Study Completion: October 31, 2019
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)