Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Obesity (BMI>30) | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folic Acid | Dietary Supplement | — | UNRESOLVED |
| İnositol | Dietary Supplement | — | UNRESOLVED |
| Low-Carbohydrate Diet | Other | — | UNRESOLVED |
| Mediterranean diet | Other | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Group Receiving Mediterranean Diet and Inositol Supplement
- description
- 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.
- interventionNames
- Dietary Supplement: İnositol
- Other: Mediterranean diet
- type
- EXPERIMENTAL
- label
- Group Receiving Mediterranean Diet and Metformin Treatment
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available