Low-Carb Versus Mediterranean Diet in PCOS

Polycystic Ovary Syndrome (PCOS) Clinical Trial

Official title:

Low-Carbohydrate Diet Versus Mediterranean Diet as Treatment for Women With Polycystic Ovary Syndrome.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05272657
• Other study ID #: Pcos2typesofDiet
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

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