An interventional study of inositol in Polycystic Ovary Syndrome (PCOS), sponsored by Istanbul Health and Technology University. Recruiting at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Istanbul Health and Technology University · Not applicable, Interventional, and Basic science
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.
Polycystic ovary syndrome (PCOS) is a common endocrine-metabolic disorder associated with reproductive and metabolic abnormalities, including insulin resistance and excess body weight. Brown adipose tissue is involved in thermogenesis and energy metabolism, and previous studies have reported reduced brown adipose tissue-related activity in women with PCOS. This study aims to further characterize brown adipose tissue-related physiological responses in women with PCOS and to examine whether these responses differ according to body mass index.
Brown adipose tissue-related heat responses will be assessed using infrared thermography of the supraclavicular region. Infrared thermography is a non-invasive, radiation-free method that allows evaluation of surface temperature changes associated with thermogenic responses. Serum UCP-1, a protein associated with brown adipose tissue, will also be measured. These assessments will be considered together with anthropometric measurements, hormonal and metabolic laboratory parameters, 24-hour dietary recall, thermogenic food consumption, and physical activity.
The study includes three groups: women with PCOS and normal body mass index, women with PCOS who are overweight or have obesity, and healthy women without PCOS. Participants in the overweight/obesity PCOS group will receive oral inositol supplementation for 12 weeks. In this group, brown adipose tissue-related thermal responses and relevant laboratory measures will be reassessed after the supplementation period to examine within-group changes.
Infrared thermography assessments will be performed after an overnight fast and during days 4-8 of the menstrual cycle to reduce variability related to hormonal fluctuations and body temperature. Participants will first rest in a thermoneutral environment. A standardized mild cold exposure will then be applied by immersing the hands in cold water for 5 minutes. Thermal images of the supraclavicular region will be obtained using a FLIR E5 Pro thermal imaging system and analyzed using FLIR Thermal Studio software.
The study is expected to provide additional information on the relationship between PCOS, body weight status, and brown adipose tissue-related physiological responses and to explore whether inositol supplementation is associated with changes in these responses.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Istanbul Health and Technology University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Relative Supraclavicular Skin Temperature (Trel)
Relative supraclavicular skin temperature (Trel) will be calculated as the difference between Tscv and the reference skin temperature (Tref) measured over the sternal region (corpus sterni), a region without brown adipose tissue, on the same thermal image (Trel = Tscv - Tref). Values from the right and left sides will be averaged to obtain a single Trel value, reported in degrees Celsius (°C).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Temperature
Body temperature will be measured and reported in degrees Celsius (°C).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Weight
Body weight will be measured and reported in kilograms (kg).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Waist Circumference
Waist circumference will be measured and reported in centimeters (cm).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Mass Index (BMI)
BMI will be calculated as body weight in kilograms divided by the square of height in meters and reported in kg/m².
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Fat Percentage
Body fat percentage will be measured using a household-type Tanita body composition scale (bioelectrical impedance) and reported as a percentage (%) of total body weight.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Basal Metabolic Rate
Basal metabolic rate will be estimated using a household-type Tanita body composition scale (bioelectrical impedance) and reported in kilocalories per day (kcal/day).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Systolic Blood Pressure
Systolic blood pressure will be measured and reported in millimeters of mercury (mmHg).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Diastolic Blood Pressure
Diastolic blood pressure will be measured and reported in millimeters of mercury (mmHg).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Follicle-Stimulating Hormone (FSH)
Serum FSH concentration will be measured and reported in mIU/mL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Luteinizing Hormone (LH)
Serum LH concentration will be measured and reported in mIU/mL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
LH/FSH Ratio
The LH/FSH ratio will be calculated by dividing serum LH (mIU/mL) by serum FSH (mIU/mL) and reported as a unitless ratio.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Estradiol (E2)
Serum estradiol concentration will be measured and reported in pg/mL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Thyroid-Stimulating Hormone (TSH)
Serum TSH concentration will be measured and reported in µIU/mL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Dehydroepiandrosterone Sulfate (DHEA-S)
Serum DHEA-S concentration will be measured and reported in µg/dL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Total Testosterone
Serum total testosterone concentration will be measured and reported in ng/mL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Modified Ferriman-Gallwey (mFG) Hirsutism Score
Hirsutism will be assessed using the modified Ferriman-Gallwey (mFG) scoring system, in which nine androgen-sensitive body areas are each scored from 0 (no terminal hair) to 4 (maximal terminal hair growth). Item scores will be summed to obtain a total score (units on a scale). The minimum score is 0 and the maximum score is 36; higher scores indicate more severe hirsutism (worse outcome).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Fasting Serum Glucose
Fasting serum glucose will be measured after an overnight fast and reported in mg/dL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Hemoglobin A1c (HbA1c)
HbA1c will be measured and reported as a percentage (%) of total hemoglobin.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Fasting Serum Insulin
Fasting serum insulin concentration will be measured and reported in µIU/mL.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR will be calculated as fasting insulin (µIU/mL) × fasting glucose (mg/dL) / 405 and reported as a unitless index.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum C-Reactive Protein (CRP)
Serum CRP concentration will be measured and reported in mg/L.
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Dietary Intake: Daily Energy Intake
Dietary intake will be assessed using a 24-hour dietary recall, and total daily energy intake will be reported in kilocalories per day (kcal/day).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Physical Activity Level Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Total physical activity will be calculated by multiplying the minutes per week spent in walking, moderate-intensity, and vigorous-intensity activities by their metabolic equivalent (MET) values (3.3, 4.0, and 8.0, respectively) and summing them, and will be reported in MET-minutes per week. The minimum value is 0, with no fixed maximum; higher values indicate greater physical activity (better outcome).
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Plan to share: Undecided — Individual participant data are not planned to be shared because the study involves sensitive clinical and health-related information, and no formal data-sharing framework has been established.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 202 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 3 months is below that.
Counting every sponsor, half of 217 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Inositol
Istanbul Health and Technology University