Status:
WITHDRAWN
Combination of D-chiro-inositol With Ketogenic Diet
Lead Sponsor:
Lo.Li.Pharma s.r.l
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
25-40 years
Phase:
NA
Brief Summary
The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with i...
Detailed Description
Weight loss is the main approach to counteract PCOS phenotype, improving ovulatory function and reducing insulin and systemic levels of free testosterone. It is not yet ascertained whether the compos...
Eligibility Criteria
Inclusion
- Women with age between 25 and 40 years
- Diagnosis of Polycystic Ovary Syndrome (PCOS)
- Diagnosis of insulin-resistance (HOMA ≥2.5)
- 26 ≤ BMI ≤32
Exclusion
- Subjects with no indication for treatment
- Pregnancy, breastfeeding
- Treatment with drugs or supplements that interfere with the mechanism of action of insulin
Key Trial Info
Start Date :
October 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05348967
Start Date
October 14 2022
End Date
November 1 2023
Last Update
June 4 2025
Active Locations (1)
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1
Sapienza University of Rome
Rome, Italy