Diets combined with metformin or inositol in women with polycystic ovary syndrome

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 20 to 40 with polycystic ovary syndrome (PCOS), insulin resistance and obesity. It compares two diets, each with metformin, inositol or folic acid.

Age

20 to 40 years

Sex

Women only

Disease stage

PCOS diagnosed by the Rotterdam 2004 criteria. Insulin resistance newly diagnosed or diagnosed within the last 3 months. Obesity grade 1 or 2 (BMI 30-40 kg/m²).

Earlier treatment

No hormonal contraceptive use within the last 3 months. No oral antidiabetic medicines. No routine medication for any reason.

Biomarker or test result

Insulin resistance (the record does not name a test value for entry).

Main reasons for not taking part

• Pregnant or breastfeeding women
• Diabetes or use of oral antidiabetic medicines
• Liver disease, kidney disease or cancer
• Psychiatric illness
• Active smokers, alcohol users or social drinkers

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 20 and 40 years old?YesNo

What the trial wants to find out

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.

The 6 groups in the trial

• Group Receiving Mediterranean Diet and Inositol SupplementTreatment being tested

  Participants in this arm will receive a hypocaloric Mediterranean diet combined with a myo-inositol supplement containing folic acid. The supplement will be administered orally as two sachets daily, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. The intervention period will be 2 months.

  Treatment: İnositol and Mediterranean diet

• Group Receiving Mediterranean Diet and Metformin TreatmentTreatment being tested

  Participants in this arm will receive a hypocaloric Mediterranean diet combined with metformin and folic acid supplementation. Metformin will be administered orally at a dose of 500 mg once daily during the first week and increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Folic acid will be administered orally at a dose of 400 µg once daily. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months.

  Treatment: Metformin, Folic Acid, and Mediterranean diet

• Mediterranean Diet Active Control GroupExisting treatment, for comparison

  Participants in this arm will receive a hypocaloric Mediterranean diet together with folic acid supplementation. Folic acid will be administered orally at a dose of 400 µg once daily. No metformin or myo-inositol supplementation will be provided. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months.

  Treatment: Folic Acid and Mediterranean diet

• Group Receiving Low-Carbohydrate Diet and Inositol SupplementTreatment being tested

  Participants in this arm will receive a hypocaloric low-carbohydrate diet combined with a myo-inositol supplement containing folic acid. The supplement will be administered orally as two sachets daily, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid. The intervention period will be 2 months.

  Treatment: İnositol and Low-Carbohydrate Diet

• Group Receiving Low-Carbohydrate Diet and Metformin TreatmentTreatment being tested

  Participants in this arm will receive a hypocaloric low-carbohydrate diet combined with metformin and folic acid supplementation. Metformin will be administered orally at a dose of 500 mg once daily during the first week and increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Folic acid will be administered orally at a dose of 400 µg once daily. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months.

  Treatment: Metformin, Folic Acid, and Low-Carbohydrate Diet

• Low-Carbohydrate Diet Active Control GroupExisting treatment, for comparison

  Participants in this arm will receive a hypocaloric low-carbohydrate diet together with folic acid supplementation. Folic acid will be administered orally at a dose of 400 µg once daily. No metformin or myo-inositol supplementation will be provided. Folic acid is included to standardize folate intake across intervention groups, as the myo-inositol supplement used in the inositol groups also contains folic acid. The intervention period will be 2 months.

  Treatment: Folic Acid and Low-Carbohydrate Diet