Clinical trial NCT05272657: Low-Carb Versus Mediterranean Diet in PCOS
Official title: Low-Carbohydrate Diet Versus Mediterranean Diet as Treatment for Women With Polycystic Ovary Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: microbiome
obesity
Mediterranean diet
low-carb diet
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.

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 . Women with PCOS are randomized into 2 treatment groups: one group on a low-carbohydrate diet and the other on a Mediterranean diet. The adhearance to a prescribed diet will be controlled through food intake diaries using a mobile application with electronic reporting forms.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: 1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
timeFrame: 12 weeks
measure: 2. Free androgen index
timeFrame: 12 weeks
Secondary outcomes:
measure: 1. Total testosterone
timeFrame: 12 weeks
measure: 2. Androstenedione
timeFrame: 12 weeks
measure: 3. Anti-Müllerian hormone (AMH)
timeFrame: 12 weeks
measure: 4. 17-Hydroxyprogesterone (17-OH-progesterone)
timeFrame: 12 weeks
measure: 5. Luteinizing hormone (LH)
timeFrame: 12 weeks
measure: 6. Follicle-stimulating hormone (FSH)
timeFrame: 12 weeks
measure: 7. Insulin
timeFrame: 12 weeks
measure: 8. Glucose
timeFrame: 12 weeks
measure: 9. Matsuda index
timeFrame: 12 weeks
measure: 10. Hirsutism
timeFrame: 12 weeks
measure: 11. Body-mass-index (BMI)
timeFrame: 12 weeks
measure: 12. waist-to-hip ratio
timeFrame: 12 weeks
measure: 13. Gut microbiome composition
timeFrame: 12 weeks
measure: 14. Inflammatory markers
timeFrame: 12 weeks
measure: 15. Untargeted metabolomics
timeFrame: 12 weeks
measure: 16. Untargeted metabolomics
timeFrame: 12 weeks
measure: 17. Serum Low-density lipoproteins (LDL)
timeFrame: 12 weeks
measure: 18. Serum high-density lipoproteins (LDL)
timeFrame: 12 weeks
measure: 19. Serum triglyceride levels, mmol/L
timeFrame: 12 weeks
measure: 20. Ovulation rate
timeFrame: 12 weeks
measure: 21. Ovarian volume
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Almazov National Medical Research Centre
name: Polina Popova, MD,PhD
role: STUDY_CHAIR
References: