NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Conditions: Ketogenic Diet, Thyroid Function, Insulin Resistance, Obesity Overweight
Interventions: Ketogenic diet
Countries: Poland
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.
Sex: FEMALE
Age: 30 Years to 50 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: Premenopausal status, defined by ongoing menstrual cycles and no history of menopause. No use of a specific diet, calorie-restricted diet, or food-elimination regimen during the preceding 12 months. Low-to-moderate habitual physical activity. Willingness to follow the prescribed ketogenic diet for 12 weeks. Willingness to participate in all study assessments. 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. Pharmacological treatment for insulin resistance. Pharmacological treatment for dyslipidemia.
- Katowice, Poland