Status:
UNKNOWN
Low-Carb Versus Mediterranean Diet in PCOS
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Polycystic Ovary Syndrome (PCOS)
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief Summary
This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two ...
Detailed Description
The study aims to clarify the impact of nutritional recommendations for women with polycystic ovary syndrome on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . W...
Eligibility Criteria
Inclusion
- Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45.
- Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group):
- signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone)
- signs of chronic anovulation
- ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche.
Exclusion
- The presence of hyperprolactinemia
- Cushing's syndrome
- Ongenital hyperplasia of the adrenal cortex
- Hypothyroidism
- Androgen-producing tumors
- Regular use of drugs and dietary supplements that affect the function of the ovaries
- Adrenal glands
- Metabolism of carbohydrates
- Lipids
- Microbiota composition during the 2 months preceding the study
- Pregnancy
- Lactation
- Significant comorbidities
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05272657
Start Date
March 30 2022
End Date
June 30 2024
Last Update
April 1 2022
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