NCT07896642|Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Sponsor study identifier
Secondary identifiers
OTHER · Turkish Medicines and Medical Devices Agency (TITCK)
interventional
60
1 country
2
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 8, 2026
Actual (reported)October 27, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Supraclavicular Skin Temperature (Tscv)
Supraclavicular skin temperature (Tscv) will be measured with a FLIR E5 Pro infrared thermal imaging camera after a standardized mild cold exposure protocol (hand immersion in cold water for 5 minutes). Mean temperatures of the right and left supraclavicular regions of interest will be averaged to obtain a single Tscv value, reported in degrees Celsius (°C), as an indicator of brown adipose tissue activity.
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Uncoupling Protein 1 (UCP-1) Level
Serum UCP-1 concentration will be measured using a commercial human sandwich ELISA kit as a biochemical marker of brown adipose tissue activity and thermogenesis, and reported in ng/L.
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Relative Supraclavicular Skin Temperature (Trel)
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Temperature
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Weight
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Waist Circumference
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Mass Index (BMI)
At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Healthy women without PCOS who will undergo the study assessments and serve as a reference group.
Women with PCOS and BMI 18.5-24.9 kg/m² who will undergo the study assessments without receiving inositol supplementation.
Women with PCOS and BMI ≥25 kg/m² who will receive oral inositol supplementation at a dose of 700 mg twice daily (1,400 mg/day) for 12 weeks. Study assessments will be performed before and after the supplementation period.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bezmialem Vakif University Faculty of Medicine Hospital
Istanbul, Turkey (Türkiye)
Istanbul Health and Technology University
Istanbul, Turkey (Türkiye)
Oliveira FR, Mamede M, Bizzi MF, Rocha ALL, Ferreira CN, Gomes KB, Candido AL, Reis FM. Brown adipose tissue activity is reduced in women with polycystic ovary syndrome. Eur J Endocrinol. 2019 Nov;181(5):473-480. doi: 10.1530/EJE-19-0505.
Haq T, Crane JD, Kanji S, Gunn E, Tarnopolsky MA, Gerstein HC, Steinberg GR, Morrison KM. Optimizing the methodology for measuring supraclavicular skin temperature using infrared thermography; implications for measuring brown adipose tissue activity in humans. Sci Rep. 2017 Sep 20;7(1):11934. doi: 10.1038/s41598-017-11537-x.
Rana Turgut Yaman
Istanbul Health and Technology University
Hayrettin Mutlu, PhD
Istanbul Health and Technology University
Seda Ateş, MD
Bezmialem Vakif University
First Submitted
October 8, 2026
First Posted
October 27, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Tienforti D, Puocci G, Venditti C, Gizzi V, Pisano C, Cocci E, Perfetto E, D'Alessandro F, Spagnolo L, Baroni MG, Barbonetti A. Metabolic Phenotype Predicts Biochemical Response to Inositol Supplementation in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. Clin Endocrinol (Oxf). 2026 Aug;105(2):237-244. doi: 10.1111/cen.70140. Epub 2026 Apr 7.
Fitz V, Graca S, Mahalingaiah S, Liu J, Lai L, Butt A, Armour M, Rao V, Naidoo D, Maunder A, Yang G, Vaddiparthi V, Witchel SF, Pena A, Spritzer PM, Li R, Tay C, Mousa A, Teede H, Ee C. Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines. J Clin Endocrinol Metab. 2024 May 17;109(6):1630-1655. doi: 10.1210/clinem/dgad762.
Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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