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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
- Sponsor
- Dicle University (Academic or other)
- Enrollment
- 90 planned
- Conditions
- PCOS (Polycystic Ovary Syndrome); Insulin Resistance; Obesity (BMI>30)
- Interventions
- Metformin; İnositol; Folic Acid; Mediterranean diet; Low-Carbohydrate Diet
- Ages
- adults
- Registry
- NCT07770711
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 Months
History
Primary completion expected
Last registry update
Registered
Started