Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07770711

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 40 Years

SexFemale

Healthy volunteersNot accepted

ConditionPCOS (Polycystic Ovary Syndrome), Insulin Resistance, Obesity (BMI>30)

Full registry 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

Treatments and study arms

Metformin

Drug

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.

İnositol

Dietary 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 Acid

Dietary 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 diet

Other

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 Diet

Other

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.

Primary outcomes

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 MonthsBaseline 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.

Study locations

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Dicle University Hospital🌐 Diyarbakır, Diyarbakır, Turkey (Türkiye)

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Elif Agacayak, MDContact

Email · Call +90 505 943 3449