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Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS

Not Yet RecruitingNA

Sponsor: Dicle University

Conditions: PCOS (Polycystic Ovary Syndrome), Insulin Resistance, Obesity (BMI>30)

Interventions: Metformin, İnositol, Folic Acid, Mediterranean diet, Low-Carbohydrate Diet

Countries: Turkey (Türkiye)

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 overview

Sex: FEMALE

Age: 20 Years to 40 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Diyarbakır, Diyarbakır, Turkey (Türkiye)