Polycystic Ovary Syndrome (PCOS)NCT07896642
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
A study testing inositol in people with Polycystic Ovary Syndrome (PCOS), run by Istanbul Health and Technology University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Sep 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- Male sex
- Age ≤17 years or ≥41 years
- Menopausal status
- BMI <18.5 kg/m²
- Pregnancy or breastfeeding
- Regular smoking or alcohol consumption
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bezmialem Vakif University Faculty of Medicine Hospital
Istanbul
Seda Ateş, MD, +90 505 392 92 74, drsedaates@yahoo.com
- Recruiting
Istanbul Health and Technology University
Istanbul
Hayrettin Mutlu, PhD, +90 505 353 55 36, hayrettin.mutlu@istun.edu.tr
About this study
Official title: Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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.
Read the detailed description
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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- inositol
- Keywords
- Polycystic Ovary Syndrome, Brown Adipose Tissue, Infrared Thermography, Inositol, Thermogenesis, Uncoupling Protein 1 (UCP-1), Nutrition
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inositolDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | No intervention | Healthy women without PCOS who will undergo the study assessments and serve as a reference group. |
| Normal-BMI PCOS Reference Group | No intervention | Women with PCOS and BMI 18.5-24.9 kg/m² who will undergo the study assessments without receiving inositol supplementation. |
| Overweight/Obesity PCOS - Inositol | Experimental | 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. Receives: Dietary Supplement: inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Secondary outcomes (24)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel study groups will be evaluated: women with PCOS and normal body mass index, women with PCOS who are overweight or have obesity and receive inositol supplementation, and healthy women without PCOS as a reference group. Participants will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Health and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Turgut Yaman, Istanbul Health and Technology University
- Investigators
- Rana Turgut Yaman, Principal investigator, Istanbul Health and Technology UniversityHayrettin Mutlu, PhD, Study chair, Istanbul Health and Technology UniversitySeda Ateş, MD, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896642
- Sponsor's protocol ID
- IstanbulHealthTU
- Other IDs
- 25-AKD-358
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 31491743Haq 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.
PubMed 28931855Tienforti 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.
PubMed 41947399Fitz 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.
PubMed 38163998
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
- ClinicalTrials.gov ID
- NCT07896642
- Acronym / sponsor ID
- IstanbulHealthTU
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Polycystic Ovary Syndrome, Brown Adipose Tissue, Infrared Thermography, Inositol, Thermogenesis, Uncoupling Protein 1 (UCP-1), Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Health and Technology UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three parallel study groups will be evaluated: women with PCOS and normal body mass index, women with PCOS who are overweight or have obesity and receive inositol supplementation, and healthy women without PCOS as a reference group. Participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | No intervention | –Healthy women without PCOS who will undergo the study assessments and serve as a reference group. |
| Normal-BMI PCOS Reference Group | No intervention | –Women with PCOS and BMI 18.5-24.9 kg/m² who will undergo the study assessments without receiving inositol supplementation. |
| Overweight/Obesity PCOS - Inositol | Experimental | Dietary Supplement: inositolWomen 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (21 listed)
- Male sex
- Age ≤17 years or ≥41 years
- Menopausal status
- BMI <18.5 kg/m²
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inositolParticipants 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. | Dietary supplement | Overweight/Obesity PCOS - Inositol |
Primary outcome
Supraclavicular Skin Temperature (Tscv)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
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.
Serum Uncoupling Protein 1 (UCP-1) Level
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
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.
24 secondary outcomes
Relative Supraclavicular Skin Temperature (Trel)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Temperature
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Weight
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Waist Circumference
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Mass Index (BMI)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Body Fat Percentage
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Basal Metabolic Rate
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Systolic Blood Pressure
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Diastolic Blood Pressure
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Follicle-Stimulating Hormone (FSH)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Luteinizing Hormone (LH)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
LH/FSH Ratio
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Estradiol (E2)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Thyroid-Stimulating Hormone (TSH)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Dehydroepiandrosterone Sulfate (DHEA-S)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum Total Testosterone
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
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Fasting Serum Glucose
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Hemoglobin A1c (HbA1c)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Fasting Serum Insulin
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)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Serum C-Reactive Protein (CRP)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Dietary Intake: Daily Energy Intake
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)
Time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 31491743Oliveira 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.
- Results publication: PubMed 28931855Haq 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.
- Results publication: PubMed 41947399Tienforti 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.
- Results publication: PubMed 38163998Fitz 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rana Turgut Yaman principal investigator
Istanbul Health and Technology University
Hayrettin Mutlu, PhD study chair
Istanbul Health and Technology University
Seda Ateş, MD study director
Bezmialem Vakif University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inositol in people with Polycystic Ovary Syndrome (PCOS), run by Istanbul Health and Technology University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RANA TURGUT YAMAN (+90 506 775 72 28, ranaturgut8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supraclavicular Skin Temperature (Tscv) (time frame: At baseline for all participants and repeated after the 12-week supplementation period in the inositol arm.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07896642, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.