← Back to all trials
Completed
NCT07775326
Dietary Macronutrients and Metabolic Markers
Conditions: Ketogenic Diet, Thyroid Function, Insulin Resistance, Obesity Overweight
Sex: Female
Ages: 30 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Location: Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice Katowice
Summary
This prospective 12-week dietary intervention study evaluated the effects of a ketogenic diet on thyroid function and glucose-insulin metabolism in premenopausal women aged 30-50 years across different adiposity categories. Participants followed an individualized low-carbohydrate ketogenic diet designed to induce and maintain nutritional ketosis. Thyroid-related outcomes included thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4). Glucose-insulin metabolism was assessed using fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), and the homeostatic model assessment of insulin resistance (HOMA-IR). Changes in body mass and anthropometric parameters were also evaluated. Outcomes were assessed before and after the 12-week intervention and compared according to baseline BMI categories.
Eligibility Criteria
Inclusion Criteria:
* Premenopausal status
* No use of a specific diet, calorie-restricted diet, or food-elimination regimen during the preceding 12 months
* Willingness to follow the prescribed ketogenic diet for 12 weeks
* Provision of written informed consent
Exclusion Criteria:
* Postmenopausal status
* Pregnancy or breastfeeding
* Previously diagnosed thyroid disease
* Thyroid hormone replacement therapy
* Use of antithyroid medication
* Use of other pharmacological treatments known to substantially affect thyroid function
* Use of dietary supplements known to substantially affect glucose or lipid metabolism before enrollment
* Use of pharmacological treatment for insulin resistance
* Use of pharmacological treatment for dyslipidemia
Source: ClinicalTrials.gov (NCT07775326). StuddyBuddy aggregates publicly available trial information.