Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
130 participants
INTERVENTIONAL
2022-03-30
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low-carbohydrate diet
subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
low-carbohydrate diet
subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
Mediterranean diet
subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
Mediterranean diet
subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
Interventions
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low-carbohydrate diet
subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
Mediterranean diet
subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
44 Years
FEMALE
No
Sponsors
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
OTHER
Responsible Party
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Principal Investigators
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Polina Popova, MD,PhD
Role: STUDY_CHAIR
Almazov National Medical Research Centre
Central Contacts
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Other Identifiers
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Pcos2typesofDiet
Identifier Type: -
Identifier Source: org_study_id
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