Clinical trial NCT04752202: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hashimoto Disease
Obesity
Keywords: Hashimoto
Obesity
Elimination diet
Thyroid gland
Adults
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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:

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Primary outcomes:
measure: 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.
timeFrame: This measurement was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This measurement was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This measurement was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This measurement was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This measurement was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This measurement was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This examination was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This examination was repeated during 3 visits every 12 weeks.
measure: 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.
timeFrame: This examination was repeated during 3 visits every 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Department of Dietetic and Clinical Nutrition; Medical University of Bialystok
Study officials:
affiliation: Medical University of Bialystok
name: Lucyna Ostrowska, Professor
role: STUDY_DIRECTOR
affiliation: Medical University of Bialystok
name: Dominika Gier, PhD
role: PRINCIPAL_INVESTIGATOR
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