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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05272657
Other study ID # Pcos2typesofDiet
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 30, 2022
Est. completion date June 30, 2024

Study information

Verified date March 2022
Source Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Contact Polina Popova, MD,PhD
Phone 702-55-95
Email pvpopova@yandex.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date June 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility 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

Study Design


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index Changes in HOMA-IR index (fasting insulin [mU/l] * fasting glucose [mmol/L]/22.5) after intervention 12 weeks
Primary 2. Free androgen index Changes in free androgen index [ (total testosterone level / sex hormone binding globulin (SHBG) level) * 100]. 12 weeks
Secondary 1. Total testosterone Changes in total testosterone levels [nmol/L] in serum after intervention 12 weeks
Secondary 2. Androstenedione Changes in androstenedione levels in serum after intervention [ng/ml] 12 weeks
Secondary 3. Anti-Müllerian hormone (AMH) Changes in AMH levels in serum after intervention [ng/ml] 12 weeks
Secondary 4. 17-Hydroxyprogesterone (17-OH-progesterone) Changes in 17-OH-progesterone levels in serum after intervention [ng/ml] 12 weeks
Secondary 5. Luteinizing hormone (LH) Changes in LH levels in serum after intervention [mU/ml] 12 weeks
Secondary 6. Follicle-stimulating hormone (FSH) Changes in FSH levels in serum after intervention [mU/ml] 12 weeks
Secondary 7. Insulin Changes in insulin levels in serum as measured with a two-hour oral glucose tolerance test (75 mg glucose in 300 ml water, blood draws at 0 minutes, 60 min and 120 min) [mU/l] 12 weeks
Secondary 8. Glucose Changes in glucose levels in plasma as measured with a two-hour oral glucose tolerance test (75 mg glucose in 300 ml water, blood draws at 0 minutes, 60 min and 120 min) [mmol/L] 12 weeks
Secondary 9. Matsuda index Changes in matsuda index after intervention measured with the formula M=10000/squareroot(glucose0 * insulin0 * Mean OGTT glucose concentration * Mean OGTT insulin concentration) 12 weeks
Secondary 10. Hirsutism measured by Ferriman-Gallwey-score (mFG-score), ranging from 0 to 36, with 0 being the best possible value and 36 the worst 12 weeks
Secondary 11. Body-mass-index (BMI) BMI measured with the formula BMI=weight [kg]/height² [m] 12 weeks
Secondary 12. waist-to-hip ratio Calculated with the formula: waist circumference/hip circumference 12 weeks
Secondary 13. Gut microbiome composition Changes in gut microbiome composition measured from stool samples via 16S-RNA gene sequencing 12 weeks
Secondary 14. Inflammatory markers Changes in inflammatory markers (Cytokines) measured by Human Cytokine/Chemokine/Growth Factor Panel A. 48 plex kit, pg/mL 12 weeks
Secondary 15. Untargeted metabolomics Serum samples will be analysed to identify biomarkers differentially changing in response to the studied diets using ultra-high performance liquid chromatography (UHPLC). 12 weeks
Secondary 16. Untargeted metabolomics Serum samples will be analysed to identify biomarkers differentially changing in response to the studied diets using ultra-high performance mass spectrometry (MS). 12 weeks
Secondary 17. Serum Low-density lipoproteins (LDL) Changes in serum Low-density lipoproteins (LDL), mmol/L 12 weeks
Secondary 18. Serum high-density lipoproteins (LDL) Changes in serum high-density lipoproteins (LDL), mmol/L 12 weeks
Secondary 19. Serum triglyceride levels, mmol/L Changes in serum triglyceride levels, mmol/L 12 weeks
Secondary 20. Ovulation rate Percent of women with ovulation recorded by serial transvaginal ultrasound after 8 weeks of participating in the study 12 weeks
Secondary 21. Ovarian volume Changes in ovarian volume (cm3) measured by transvaginal ultrasound in early follicular phase or after 3 months of amenorrhea 12 weeks
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