NCT07770711Recruiting
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
Comparison of Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 13 Aug 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Dicle University
- Diseases
- Obesity
- NCT number
- NCT07770711
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 13 Aug 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those taking routine medication for any reason
Other illness
- Diabetes diagnosis, use of oral antidiabetic agents
- Chronic diseases (liver, kidney diseases, cancer)
- Psychiatric illnesses
Other
- Pregnant or breastfeeding women
- Those undergoing/contemplating IVF treatment
- Early menopause diagnosis
- 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
Who the study is looking for
- 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)
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dicle University Hospital Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.