PCOS (Polycystic Ovary Syndrome)NCT07770711
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
A study testing Metformin, İnositol and Folic Acid in people with PCOS (Polycystic Ovary Syndrome) and Insulin Resistance, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome), Insulin Resistance, Obesity (BMI>30)
- What is being tested?
- Metformin, İnositol and Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2026to Sep 2027
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20-40
- Diagnosed with PCOS (Rotterdam, 2004)
- Insulin resistant (newly diagnosed or diagnosed within the last 3 months)
- Obese according to the World Health Organization (2006) in grades 1 and 2 (BMI: 30-40 kg/m²)
Who cannot join
- Pregnant or breastfeeding women
- Those undergoing/contemplating IVF treatment
- Early menopause diagnosis
- Diabetes diagnosis, use of oral antidiabetic agents
- Chronic diseases (liver, kidney diseases, cancer)
- Psychiatric illnesses
Show all 10Show fewer
- Those taking routine medication for any reason
- Use of hormonal contraceptive methods within the last 3 months
- Active smokers and alcohol users or social drinkers
- Change in body weight of more than 10% in the last 6 months for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dicle University Hospital
Diyarbakır, Diyarbakır, 21280
Elif Agacayak, MD, +90 505 943 3449, drelifagacayak@gmail.com
About this study
Official title: Comparison of Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With Polycystic Ovary Syndrome
Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a complex and widespread endocrine disorder of unknown etiology, affecting 5-20% of women of reproductive age worldwide according to different diagnostic criteria. According to the Rotterdam criteria, PCOS is characterized by the presence of two of the following: hyperandrogenism, chronic anovulation, and polycystic ovary morphology. While the causes of PCOS are not yet fully defined, insulin resistance (IR) is considered one of the key etiological components. IR, frequently observed in PCOS, often mediates increased total and abdominal fat accumulation. The close relationship between PCOS, hyperandrogenism, hyperinsulinemia, and IR also increases the risk of metabolic syndrome. As a result of the lifelong pathological condition of PCOS, these women are at high risk for obesity, metabolic dysfunction, vascular dysfunction, malignancy, reproductive complications, and mood disorders. For many years, effective methods have been sought to treat hormonal imbalances associated with PCOS in order to restore regular menstrual cycles and ovulation. It has been reported that women with PCOS should reduce their energy intake through diet and implement dietary models that promote weight loss. While various dietary interventions in the literature, such as the ketogenic diet (KD), low-carbohydrate diet (LCD), and Mediterranean diet (MD), have shown positive effects on PCOS as a first-line treatment method, the definition of PCOS-specific medical nutritional therapy is not clear. Since PCOS is a chronic disease requiring lifelong management, and considering the side effect profile and difficulty of implementing the ketogenic diet, which appears promising in the short term, this study will evaluate the effects of the Mediterranean diet and a non-ketogenic low-carbohydrate diet. Metformin and inositol treatments will also be included in this comparison, and thanks to an active control group (folic acid), the effect of these dietary models alone against these pharmacological treatments can also be examined. This will allow for the evaluation of the effects of existing treatment approaches both individually and in combination. The study is designed as a randomized controlled, open-label, parallel design. The study will include 102 obese women diagnosed with PCOS and insulin resistance, who will be randomly assigned to two diet groups (AD and DKD). Each diet group will be further divided into three subgroups, and these subgroups will also receive metformin, inositol, or active control (folic acid) treatments. The intervention period of the study is two months, and adherence to diet and medication will be monitored at regular intervals. Biochemical findings, anthropometric measurements, body composition measurements, and the Nutritional Power Scale will be repeated at the beginning and end of the two-month study. The findings of this study will contribute to determining the optimal sequence or combination of dietary models, increasingly common food supplements, and existing medical agents in terms of treatment effectiveness.
- Being tested
- Metformin, İnositol, Folic Acid, Mediterranean diet, Low-Carbohydrate Diet
- Keywords
- Mediterranean diet, low-carbohydrate diet, insulin resistance, inositol, pcos
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin will be administered orally for 2 months. Treatment will begin at 500 mg once daily during the first week and will be increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Dose escalation is intended to improve gastrointestinal tolerability while achieving the target maintenance dose.
İnositolDietary supplement
Myo-inositol will be administered orally as a powdered sachet formulation. Participants will receive two sachets daily for 2 months, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid.
Folic AcidDietary supplement
Folic acid will be administered orally at a dose of 400 µg once daily for 2 months. Folic acid is provided to participants in the metformin and control groups to standardize folate intake across intervention groups, as the myo-inositol supplement administered in the inositol groups also contains 400 µg of folic acid per day.
Mediterranean dietOther
Participants will receive individualized hypocaloric Mediterranean diet counseling for 2 months. Daily energy requirements will be calculated individually, and meal plans will be prescribed with an energy deficit of approximately 500 kcal/day to promote weight loss. The dietary pattern will emphasize vegetables, fruits, whole grains, legumes, nuts, olive oil as the principal source of fat, moderate consumption of fish, poultry, and low-fat dairy products, and limited consumption of red and processed meat, refined grains, and foods high in added sugars and saturated fat. Dietary adherence will be monitored at regular follow-up visits throughout the intervention period.
Low-Carbohydrate DietOther
Participants will receive individualized hypocaloric low-carbohydrate diet counseling for 2 months. Daily energy requirements will be calculated individually, and meal plans will be prescribed with an energy deficit of approximately 500 kcal/day to promote weight loss. The diet will provide 50-130 g/day of carbohydrates or approximately 25-30% of total daily energy from carbohydrates. After achieving the carbohydrate target, the remaining energy intake will be distributed to provide approximately 15-30% of total energy from protein and 35-50% from fat, according to individual energy requirements. Dietary adherence will be monitored at regular follow-up visits throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Group Receiving Mediterranean Diet and Inositol Supplement | Experimental | Participants in this arm will receive a hypocaloric Mediterranean diet combined with a myo-inositol supplement containing folic acid. The supplement will be administered orally as two sachets daily, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. The intervention period will be 2 months. Receives: Dietary Supplement: İnositol; Other: Mediterranean diet |
| Group Receiving Mediterranean Diet and Metformin Treatment | Experimental | Participants in this arm will receive a hypocaloric Mediterranean diet combined with metformin and folic acid supplementation. Metformin will be administered orally at a dose of 500 mg once daily during the first week and increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Folic acid will be administered orally at a dose of 400 µg once daily. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. Receives: Drug: Metformin; Dietary Supplement: Folic Acid; Other: Mediterranean diet |
| Mediterranean Diet Active Control Group | Active comparator | Participants in this arm will receive a hypocaloric Mediterranean diet together with folic acid supplementation. Folic acid will be administered orally at a dose of 400 µg once daily. No metformin or myo-inositol supplementation will be provided. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. Receives: Dietary Supplement: Folic Acid; Other: Mediterranean diet |
| Group Receiving Low-Carbohydrate Diet and Inositol Supplement | Experimental | Participants in this arm will receive a hypocaloric low-carbohydrate diet combined with a myo-inositol supplement containing folic acid. The supplement will be administered orally as two sachets daily, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. The intervention period will be 2 months. Receives: Dietary Supplement: İnositol; Other: Low-Carbohydrate Diet |
| Group Receiving Low-Carbohydrate Diet and Metformin Treatment | Experimental | Participants in this arm will receive a hypocaloric low-carbohydrate diet combined with metformin and folic acid supplementation. Metformin will be administered orally at a dose of 500 mg once daily during the first week and increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Folic acid will be administered orally at a dose of 400 µg once daily. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. Receives: Drug: Metformin; Dietary Supplement: Folic Acid; Other: Low-Carbohydrate Diet |
| Low-Carbohydrate Diet Active Control Group | Active comparator | Participants in this arm will receive a hypocaloric low-carbohydrate diet together with folic acid supplementation. Folic acid will be administered orally at a dose of 400 µg once daily. No metformin or myo-inositol supplementation will be provided. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. Receives: Dietary Supplement: Folic Acid; Other: Low-Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 Months
Insulin resistance will be assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting serum insulin concentrations. The primary outcome will be the change in HOMA-IR from baseline to 2 months. Lower HOMA-IR values indicate improved insulin sensitivity.
Measured: Baseline and 2 months
Secondary outcomes (5)
Change in Body Weight From Baseline to 2 Months
Body weight will be measured in kilograms (kg). Change in body weight will be calculated as the value at 2 months minus the baseline value.
Measured: Baseline and 2 months
Change in Body Mass Index From Baseline to 2 Months
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Change in BMI will be calculated as the value at 2 months minus the baseline value.
Measured: Baseline and 2 months
Change in Body Fat Percentage From Baseline to 2 Months
Body fat percentage will be assessed by bioelectrical impedance analysis (BIA) and reported as a percentage (%). Change in body fat percentage will be calculated as the value at 2 months minus the baseline value.
Measured: Baseline to 2 Months
Change in Body Fat Mass From Baseline to 2 Months
Body fat mass will be assessed by bioelectrical impedance analysis (BIA) and reported in kilograms (kg). Change in body fat mass will be calculated as the value at 2 months minus the baseline value.
Measured: Baseline to 2 Months
Change in Fasting Serum Visfatin Concentration (ng/mL) From Baseline to 2 Months
Fasting serum visfatin concentration will be measured in nanograms per milliliter (ng/mL) using an enzyme-linked immunosorbent assay (ELISA). The outcome will be reported as the change in serum visfatin concentration from baseline to 2 months, calculated as the 2-month value minus the baseline value.
Measured: Baseline to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start13 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 2×3 factorial, parallel-group design. Participants will first be allocated to one of two hypocaloric dietary interventions (Mediterranean diet or low-carbohydrate diet). Within each dietary group, participants will be further randomized to receive metformin, inositol, or folic acid (active control), resulting in six intervention arms. Randomization will be performed using computer-generated permuted block randomization with variable block sizes (6 and 12), stratified by age (\<30 vs. ≥30 years) and body mass index (30.0-34.9 vs. ≥35.0 kg/m²). Allocation concealment will be maintained until randomization, after which the study will be conducted as an open-label trial.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra UCAR, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770711
- Sponsor's protocol ID
- DU-BVD-EU-01
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07770711
- Acronym / sponsor ID
- DU-BVD-EU-01
- Keywords
- Mediterranean diet, low-carbohydrate diet, insulin resistance, inositol, pcos
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Aug 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.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.
Detailed description
Polycystic ovary syndrome (PCOS) is a complex and widespread endocrine disorder of unknown etiology, affecting 5-20% of women of reproductive age worldwide according to different diagnostic criteria. According to the Rotterdam criteria, PCOS is characterized by the presence of two of the following: hyperandrogenism, chronic anovulation, and polycystic ovary morphology. While the causes of PCOS are not yet fully defined, insulin resistance (IR) is considered one of the key etiological components. IR, frequently observed in PCOS, often mediates increased total and abdominal fat accumulation. The close relationship between PCOS, hyperandrogenism, hyperinsulinemia, and IR also increases the risk of metabolic syndrome. As a result of the lifelong pathological condition of PCOS, these women are at high risk for obesity, metabolic dysfunction, vascular dysfunction, malignancy, reproductive complications, and mood disorders. For many years, effective methods have been sought to treat hormonal imbalances associated with PCOS in order to restore regular menstrual cycles and ovulation. It has been reported that women with PCOS should reduce their energy intake through diet and implement dietary models that promote weight loss. While various dietary interventions in the literature, such as the ketogenic diet (KD), low-carbohydrate diet (LCD), and Mediterranean diet (MD), have shown positive effects on PCOS as a first-line treatment method, the definition of PCOS-specific medical nutritional therapy is not clear. Since PCOS is a chronic disease requiring lifelong management, and considering the side effect profile and difficulty of implementing the ketogenic diet, which appears promising in the short term, this study will evaluate the effects of the Mediterranean diet and a non-ketogenic low-carbohydrate diet. Metformin and inositol treatments will also be included in this comparison, and thanks to an active control group (folic acid), the effect of these dietary models alone against these pharmacological treatments can also be examined. This will allow for the evaluation of the effects of existing treatment approaches both individually and in combination. The study is designed as a randomized controlled, open-label, parallel design. The study will include 102 obese women diagnosed with PCOS and insulin resistance, who will be randomly assigned to two diet groups (AD and DKD). Each diet group will be further divided into three subgroups, and these subgroups will also receive metformin, inositol, or active control (folic acid) treatments. The intervention period of the study is two months, and adherence to diet and medication will be monitored at regular intervals. Biochemical findings, anthropometric measurements, body composition measurements, and the Nutritional Power Scale will be repeated at the beginning and end of the two-month study. The findings of this study will contribute to determining the optimal sequence or combination of dietary models, increasingly common food supplements, and existing medical agents in terms of treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants will be randomized in a 2×3 factorial, parallel-group design. Participants will first be allocated to one of two hypocaloric dietary interventions (Mediterranean diet or low-carbohydrate diet). Within each dietary group, participants will be further randomized to receive metformin, inositol, or folic acid (active control), resulting in six intervention arms. Randomization will be performed using computer-generated permuted block randomization with variable block sizes (6 and 12), stratified by age (<30 vs. ≥30 years) and body mass index (30.0-34.9 vs. ≥35.0 kg/m²). Allocation concealment will be maintained until randomization, after which the study will be conducted as an open-label trial.
| Arm | Type | Receives |
|---|---|---|
| Group Receiving Mediterranean Diet and Inositol Supplement | Experimental | Dietary Supplement: İnositol, Other: Mediterranean dietParticipants in this arm will receive a hypocaloric Mediterranean diet combined with a myo-inositol supplement containing folic acid. The supplement will be administered orally as two sachets daily, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. The intervention period will be 2 months. |
| Group Receiving Mediterranean Diet and Metformin Treatment | Experimental | Drug: Metformin, Dietary Supplement: Folic Acid, Other: Mediterranean dietParticipants in this arm will receive a hypocaloric Mediterranean diet combined with metformin and folic acid supplementation. Metformin will be administered orally at a dose of 500 mg once daily during the first week and increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Folic acid will be administered orally at a dose of 400 µg once daily. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. |
| Mediterranean Diet Active Control Group | Active comparator | Dietary Supplement: Folic Acid, Other: Mediterranean dietParticipants in this arm will receive a hypocaloric Mediterranean diet together with folic acid supplementation. Folic acid will be administered orally at a dose of 400 µg once daily. No metformin or myo-inositol supplementation will be provided. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. |
| Group Receiving Low-Carbohydrate Diet and Inositol Supplement | Experimental | Dietary Supplement: İnositol, Other: Low-Carbohydrate DietParticipants in this arm will receive a hypocaloric low-carbohydrate diet combined with a myo-inositol supplement containing folic acid. The supplement will be administered orally as two sachets daily, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. The intervention period will be 2 months. |
| Group Receiving Low-Carbohydrate Diet and Metformin Treatment | Experimental | Drug: Metformin, Dietary Supplement: Folic Acid, Other: Low-Carbohydrate DietParticipants in this arm will receive a hypocaloric low-carbohydrate diet combined with metformin and folic acid supplementation. Metformin will be administered orally at a dose of 500 mg once daily during the first week and increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Folic acid will be administered orally at a dose of 400 µg once daily. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. |
| Low-Carbohydrate Diet Active Control Group | Active comparator | Dietary Supplement: Folic Acid, Other: Low-Carbohydrate DietParticipants in this arm will receive a hypocaloric low-carbohydrate diet together with folic acid supplementation. Folic acid will be administered orally at a dose of 400 µg once daily. No metformin or myo-inositol supplementation will be provided. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 20-40
- Diagnosed with PCOS (Rotterdam, 2004)
- Insulin resistant (newly diagnosed or diagnosed within the last 3 months)
- Obese according to the World Health Organization (2006) in grades 1 and 2 (BMI: 30-40 kg/m²)
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
- Those undergoing/contemplating IVF treatment
- Early menopause diagnosis
- Diabetes diagnosis, use of oral antidiabetic agents
- Chronic diseases (liver, kidney diseases, cancer)
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 |
|---|---|---|
| MetforminMetformin will be administered orally for 2 months. Treatment will begin at 500 mg once daily during the first week and will be increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Dose escalation is intended to improve gastrointestinal tolerability while achieving the target maintenance dose. | Drug | Group Receiving Low-Carbohydrate Diet and Metformin Treatment, Group Receiving Mediterranean Diet and Metformin Treatment |
| İnositolMyo-inositol will be administered orally as a powdered sachet formulation. Participants will receive two sachets daily for 2 months, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. | Dietary supplement | Group Receiving Low-Carbohydrate Diet and Inositol Supplement, Group Receiving Mediterranean Diet and Inositol Supplement |
| Folic AcidFolic acid will be administered orally at a dose of 400 µg once daily for 2 months. Folic acid is provided to participants in the metformin and control groups to standardize folate intake across intervention groups, as the myo-inositol supplement administered in the inositol groups also contains 400 µg of folic acid per day. | Dietary supplement | Group Receiving Low-Carbohydrate Diet and Metformin Treatment, Group Receiving Mediterranean Diet and Metformin Treatment, Low-Carbohydrate Diet Active Control Group, Mediterranean Diet Active Control Group |
| Mediterranean dietParticipants will receive individualized hypocaloric Mediterranean diet counseling for 2 months. Daily energy requirements will be calculated individually, and meal plans will be prescribed with an energy deficit of approximately 500 kcal/day to promote weight loss. The dietary pattern will emphasize vegetables, fruits, whole grains, legumes, nuts, olive oil as the principal source of fat, moderate consumption of fish, poultry, and low-fat dairy products, and limited consumption of red and processed meat, refined grains, and foods high in added sugars and saturated fat. Dietary adherence will be monitored at regular follow-up visits throughout the intervention period. | Other | Group Receiving Mediterranean Diet and Inositol Supplement, Group Receiving Mediterranean Diet and Metformin Treatment, Mediterranean Diet Active Control Group |
| Low-Carbohydrate DietParticipants will receive individualized hypocaloric low-carbohydrate diet counseling for 2 months. Daily energy requirements will be calculated individually, and meal plans will be prescribed with an energy deficit of approximately 500 kcal/day to promote weight loss. The diet will provide 50-130 g/day of carbohydrates or approximately 25-30% of total daily energy from carbohydrates. After achieving the carbohydrate target, the remaining energy intake will be distributed to provide approximately 15-30% of total energy from protein and 35-50% from fat, according to individual energy requirements. Dietary adherence will be monitored at regular follow-up visits throughout the intervention period. | Other | Group Receiving Low-Carbohydrate Diet and Inositol Supplement, Group Receiving Low-Carbohydrate Diet and Metformin Treatment, Low-Carbohydrate Diet Active Control Group |
Primary outcome
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 Months
Time frame: Baseline and 2 months
Insulin resistance will be assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting serum insulin concentrations. The primary outcome will be the change in HOMA-IR from baseline to 2 months. Lower HOMA-IR values indicate improved insulin sensitivity.
5 secondary outcomes
Change in Body Weight From Baseline to 2 Months
Time frame: Baseline and 2 months
Change in Body Mass Index From Baseline to 2 Months
Time frame: Baseline and 2 months
Change in Body Fat Percentage From Baseline to 2 Months
Time frame: Baseline to 2 Months
Change in Body Fat Mass From Baseline to 2 Months
Time frame: Baseline to 2 Months
Change in Fasting Serum Visfatin Concentration (ng/mL) From Baseline to 2 Months
Time frame: Baseline to 2 Months
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin, İnositol and Folic Acid in people with PCOS (Polycystic Ovary Syndrome) and Insulin Resistance, run by Dicle University at 1 site 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 4 inclusion and 10 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 16 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 1 site 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 Esra Ucar, MSc (+90 555 993 1894, esra.ucar@dicle.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 Months (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.