Low-Carb Versus Mediterranean Diet in PCOS

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome (PCOS)
• Intervention / Treatment: Other: low-carbohydrate diet; Other: Mediterranean diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Polina Popova, MD,PhD; Phone Number: 007(812) 702-55-95; Email: pvpopova@yandex.ru
• Study Contact Backup: Name: Elena Vasiukova; Email: elenavasukova2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-carbohydrate diet; 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 low-carbohydrate diet.
Experimental: Mediterranean 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 Mediterranean diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
2. Free androgen index	Changes in free androgen index [ (total testosterone level / sex hormone binding globulin (SHBG) level) * 100].	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Total testosterone	Changes in total testosterone levels [nmol/L] in serum after intervention	12 weeks
2. Androstenedione	Changes in androstenedione levels in serum after intervention [ng/ml]	12 weeks
3. Anti-Müllerian hormone (AMH)	Changes in AMH levels in serum after intervention [ng/ml]	12 weeks
4. 17-Hydroxyprogesterone (17-OH-progesterone)	Changes in 17-OH-progesterone levels in serum after intervention [ng/ml]	12 weeks
5. Luteinizing hormone (LH)	Changes in LH levels in serum after intervention [mU/ml]	12 weeks
6. Follicle-stimulating hormone (FSH)	Changes in FSH levels in serum after intervention [mU/ml]	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]	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]	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)	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	12 weeks
11. Body-mass-index (BMI)	BMI measured with the formula BMI=weight [kg]/height² [m]	12 weeks
12. waist-to-hip ratio	Calculated with the formula: waist circumference/hip circumference	12 weeks
13. Gut microbiome composition	Changes in gut microbiome composition measured from stool samples via 16S-RNA gene sequencing	12 weeks
14. Inflammatory markers	Changes in inflammatory markers (Cytokines) measured by Human Cytokine/Chemokine/Growth Factor Panel A. 48 plex kit, pg/mL	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).	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).	12 weeks
17. Serum Low-density lipoproteins (LDL)	Changes in serum Low-density lipoproteins (LDL), mmol/L	12 weeks
18. Serum high-density lipoproteins (LDL)	Changes in serum high-density lipoproteins (LDL), mmol/L	12 weeks
19. Serum triglyceride levels, mmol/L	Changes in serum triglyceride levels, mmol/L	12 weeks
20. Ovulation rate	Percent of women with ovulation recorded by serial transvaginal ultrasound after 8 weeks of participating in the study	12 weeks
21. Ovarian volume	Changes in ovarian volume (cm3) measured by transvaginal ultrasound in early follicular phase or after 3 months of amenorrhea	12 weeks

Collaborators and Investigators

• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Investigators: Study Chair: Polina Popova, MD,PhD, Almazov National Medical Research Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 20, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: obesity; microbiome; Mediterranean diet; low-carb diet
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: Pcos2typesofDiet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No