An interventional study of low-carbohydrate diet and Mediterranean diet in Polycystic Ovary Syndrome (PCOS), sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. Status unknown. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Not applicable, Interventional, and Treatment
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.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 130 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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):
Exclusion Criteria:
subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
Other: low-carbohydrate diet
subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
Other: Mediterranean diet
subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
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
Time frame: 12 weeks
2. Free androgen index
Changes in free androgen index \[ (total testosterone level / sex hormone binding globulin (SHBG) level) \* 100\].
Time frame: 12 weeks
1. Total testosterone
Changes in total testosterone levels \[nmol/L\] in serum after intervention
Time frame: 12 weeks
2. Androstenedione
Changes in androstenedione levels in serum after intervention \[ng/ml\]
Time frame: 12 weeks
3. Anti-Müllerian hormone (AMH)
Changes in AMH levels in serum after intervention \[ng/ml\]
Time frame: 12 weeks
4. 17-Hydroxyprogesterone (17-OH-progesterone)
Changes in 17-OH-progesterone levels in serum after intervention \[ng/ml\]
Time frame: 12 weeks
5. Luteinizing hormone (LH)
Changes in LH levels in serum after intervention \[mU/ml\]
Time frame: 12 weeks
6. Follicle-stimulating hormone (FSH)
Changes in FSH levels in serum after intervention \[mU/ml\]
Time frame: 12 weeks
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) \[mU/l\]
Time frame: 12 weeks
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) \[mmol/L\]
Time frame: 12 weeks
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)
Time frame: 12 weeks
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
Time frame: 12 weeks
11. Body-mass-index (BMI)
BMI measured with the formula BMI=weight \[kg\]/height² \[m\]
Time frame: 12 weeks
12. waist-to-hip ratio
Calculated with the formula: waist circumference/hip circumference
Time frame: 12 weeks
13. Gut microbiome composition
Changes in gut microbiome composition measured from stool samples via 16S-RNA gene sequencing
Time frame: 12 weeks
14. Inflammatory markers
Changes in inflammatory markers (Cytokines) measured by Human Cytokine/Chemokine/Growth Factor Panel A. 48 plex kit, pg/mL
Time frame: 12 weeks
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).
Time frame: 12 weeks
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).
Time frame: 12 weeks
17. Serum Low-density lipoproteins (LDL)
Changes in serum Low-density lipoproteins (LDL), mmol/L
Time frame: 12 weeks
18. Serum high-density lipoproteins (LDL)
Changes in serum high-density lipoproteins (LDL), mmol/L
Time frame: 12 weeks
19. Serum triglyceride levels, mmol/L
Changes in serum triglyceride levels, mmol/L
Time frame: 12 weeks
20. Ovulation rate
Percent of women with ovulation recorded by serial transvaginal ultrasound after 8 weeks of participating in the study
Time frame: 12 weeks
21. Ovarian volume
Changes in ovarian volume (cm3) measured by transvaginal ultrasound in early follicular phase or after 3 months of amenorrhea
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health