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

Medical University of Bialystok

Status: Completed

Conditions: Obesity; Hashimoto Disease

Treatments: Behavioral: Individually balanced reducing diets (without elimination); Behavioral: Individually balanced elimination/reducing diets

Study type: Interventional

Funder types: Other

Identifiers

NCT04752202

R-I-002/187/2019

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

---

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Test group (group A)

Experimental group

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.

Treatment:

Behavioral: Individually balanced elimination/reducing diets

Control group (group B)

Other group

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.

Treatment:

Behavioral: Individually balanced reducing diets (without elimination)