NCT07770711 Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
| NCT ID | NCT07770711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dicle University |
| Condition | PCOS (Polycystic Ovary Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-08-13 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-08-13 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07770711 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 40 Years, studying PCOS (Polycystic Ovary Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07770711 currently recruiting?
Yes, NCT07770711 is actively recruiting participants. Contact the research team at esra.ucar@dicle.edu.tr for enrollment information.
Where is the NCT07770711 trial being conducted?
This trial is being conducted at Diyarbakır, Turkey (Türkiye).
Who is sponsoring the NCT07770711 clinical trial?
NCT07770711 is sponsored by Dicle University. The trial plans to enroll 90 participants.