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RECRUITING

NCT07896642

Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography

Sponsor: Istanbul Health and Technology University

View on ClinicalTrials.gov

Summary

This study will investigate brown adipose tissue-related physiological responses in women with polycystic ovary syndrome (PCOS). Women with PCOS who have normal body mass index, women with PCOS who are overweight or have obesity, and healthy women will be compared. Brown adipose tissue-related heat responses will be evaluated using non-invasive infrared thermography of the supraclavicular region, together with serum UCP-1 levels and metabolic measurements. Participants in the overweight/obesity PCOS group will receive an inositol supplement for 12 weeks, and measurements will be repeated after supplementation. The study will also examine possible relationships between surface temperature responses, dietary intake, physical activity, body measurements, and metabolic and hormonal markers.

Official title: Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09

Completion Date

2026-12

Last Updated

2026-10-27

Healthy Volunteers

Yes

Conditions

Polycystic Ovary Syndrome (PCOS)

Interventions

DIETARY_SUPPLEMENT

inositol

Participants in the overweight/obesity PCOS arm (BMI ≥25 kg/m²; n=20) will receive an orally administered inositol dietary supplement for 12 weeks. The supplement will provide 700 mg of inositol twice daily (total daily dose: 1,400 mg). The intervention is based on the use of myo-inositol and D-chiro-inositol, which are commonly used in PCOS management. The product will be selected from commercially available dietary supplements approved by the Republic of Türkiye Ministry of Agriculture and Forestry and will comply with applicable national regulations. Participants will be monitored throughout the supplementation period for tolerability and adverse effects. If an adverse effect or intolerance considered related to inositol occurs, the participant will be withdrawn from the study. Study assessments in this arm will be performed at baseline and after the 12-week supplementation period.

Inclusion Criteria: * Female participants aged 18-40 years * Premenopausal status * Ability and willingness to provide written informed consent * For the Overweight/Obesity PCOS - Inositol and Normal-BMI PCOS Reference Group arms: * Diagnosis of polycystic ovary syndrome (PCOS) established by an obstetrician and gynecologist according to the Rotterdam criteria * For the Normal-BMI PCOS Reference Group arm: * BMI 18.5-24.9 kg/m² * For the Overweight/Obesity PCOS - Inositol arm: * BMI ≥25 kg/m² * For the Healthy Control Group arm: * BMI 18.5-24.9 kg/m² * Regular menstrual cycles * Normal ovarian morphology * No diagnosis of PCOS Exclusion Criteria: * Male sex * Age ≤17 years or ≥41 years * Menopausal status * BMI \<18.5 kg/m² * Pregnancy or breastfeeding * Regular smoking or alcohol consumption * Being highly physically active, defined as regular exercise during the previous 6 months or being a professional athlete * Presence of endocrine disorders that may affect the diagnosis of PCOS, including thyroid disease, congenital adrenal hyperplasia, androgen-secreting tumors, or Cushing syndrome * Any intervention for PCOS treatment within the previous 6 months, including pharmacological treatment or alternative approaches such as acupuncture * History of ovarian surgery * Presence of any of the following conditions: * Secondary hypertension * Cardiovascular, cerebrovascular, renal, hepatic, thyroid, or pulmonary disease * Any type of cancer * Acute infection * Autoimmune disease * Severe psychological or neurological disease * Following a special diet that may affect metabolic rate, including vegetarian, vegan, diabetic, or low-calorie diets * Regular use of dietary supplements such as probiotics or prebiotics * History of obesity-specific treatment, including bariatric surgery or anti-obesity medication * Regular medication use within the previous 3 months or currently, particularly oral contraceptives, hormonal medications, or medications affecting metabolism

Locations (2)

Bezmialem Vakif University Faculty of Medicine Hospital

Istanbul, Turkey (Türkiye)

Istanbul Health and Technology University