Status:
UNKNOWN
Effects of Fasting Mimicking Diet (FMD) in Women With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
University of Salento
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in reproductive-aged women, affecting 6-21% (depending on the applied diagnostic criteria) of this population worldwide. PCOS is char...
Detailed Description
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in reproductive-aged women, affecting 6-21% (depending on the applied diagnostic criteria) of this population worldwide. PCOS is char...
Eligibility Criteria
Inclusion
- Female 18-40 years
- BMI 20-40
- Reproductive age women with PCOS diagnosis
- Irregular menstrual cycles
- Chronic oligo/anovulation defined as an intermenstrual interval of \>45 days
- \< 8 menstrual cycles/year
- evidence of either hyperandrogenemia (elevation of total or free testosterone above the normal range for women)
- clinical hyerandrogenism (hirsutism and or acne)
- 3 years from menarche
- Agree to avoidance of pregnancy and to use barrier contraception for duration of study
Exclusion
- • Clinically ascertained presence of type I and type II Diabetes
- Pregnancy and/or nursing
- Medication exclusion
- Use of medications and/or supplements that influence either ovarian function or insulin sensitivity, within 2 months: including oral contraceptive pills, hormonal implants, anti-androgens, antipsychotics or antihypertensives metformin, glucocorticoids, and/or health food remedies other than multi-vitamins and calcium;
- Subjects who are on oral contraception, metformin, or nutritional supplements must agree to discontinue these drugs and undergo an 8 week washout period before the tests are performed
- Other drugs that cannot be suspended during the FMD phase
- Alcohol usage more than 7 drinks/week
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05196568
Start Date
July 1 2021
End Date
January 1 2025
Last Update
December 5 2023
Active Locations (1)
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1
Anna Maria Giudetti
Lecce, Italy, 73100