Inositol and Metformin with Mediterranean or Low-Carb Diets in Women with PCOS
Official title: Comparison of Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With Polycystic Ovary Syndrome
Run by Dicle University · NCT07770711 · Data updated 2026-11-12
This trial tests whether adding inositol, metformin, or folic acid to either a Mediterranean or a low-carbohydrate diet helps women with PCOS and insulin resistance lose weight and improve metabolic markers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Dicle University Academic / other |
| Locations | 1 site (Diyarbakır, Diyarbakır) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07770711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20-40 with PCOS, obesity (BMI 30-40), and insulin resistance.
✕Probably not a fit
Those without insulin resistance, with BMI outside 30-40, or with conditions excluding participation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label study enrolls 102 obese women with PCOS and insulin resistance to compare six intervention groups combining two diet patterns (Mediterranean or low-carbohydrate) with three supplements (metformin, inositol, or folic acid) over two months. Primary outcome is the change in insulin resistance as measured by HOMA-IR, with secondary outcomes including body composition, biochemical parameters, and hedonic hunger. Participants are adults aged 20-40 with PCOS diagnosed by Rotterdam criteria and BMI 30-40 kg/m2. The trial is conducted at Dicle University Hospital in Diyarbakır, Turkey, and aims to clarify which dietary-supplement strategy best improves metabolic health in this population.
Why it matters
Potential benefit: If successful, the study could identify dietary and supplement combinations that better reduce insulin resistance and improve metabolic health in women with PCOS and obesity.
How similar studies have gone: Previous research suggests dietary patterns and supplements can impact PCOS-related metabolism, but direct head-to-head comparisons of these combinations are limited, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dicle University Hospital
Diyarbakır, Diyarbakır, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Esra Ucar, MSc
- Email: esra.ucar@dicle.edu.tr
- Phone: +90 555 993 1894
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.