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Low-Carb Versus Mediterranean Diet in PCOS

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low-carbohydrate diet
Mediterranean diet
Sponsored by
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring microbiome, obesity, Mediterranean diet, low-carb diet

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    low-carbohydrate diet

    Mediterranean diet

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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
    2. Free androgen index
    Changes in free androgen index [ (total testosterone level / sex hormone binding globulin (SHBG) level) * 100].

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 28, 2022
    Last Updated
    March 20, 2022
    Sponsor
    Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05272657
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome (PCOS)
    Keywords
    microbiome, obesity, Mediterranean diet, low-carb diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    low-carbohydrate diet
    Arm Type
    Experimental
    Arm Description
    subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
    Arm Title
    Mediterranean diet
    Arm Type
    Experimental
    Arm Description
    subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
    Intervention Type
    Other
    Intervention Name(s)
    low-carbohydrate diet
    Intervention Description
    subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
    Intervention Type
    Other
    Intervention Name(s)
    Mediterranean diet
    Intervention Description
    subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
    Primary Outcome Measure Information:
    Title
    1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
    Description
    Changes in HOMA-IR index (fasting insulin [mU/l] * fasting glucose [mmol/L]/22.5) after intervention
    Time Frame
    12 weeks
    Title
    2. Free androgen index
    Description
    Changes in free androgen index [ (total testosterone level / sex hormone binding globulin (SHBG) level) * 100].
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    1. Total testosterone
    Description
    Changes in total testosterone levels [nmol/L] in serum after intervention
    Time Frame
    12 weeks
    Title
    2. Androstenedione
    Description
    Changes in androstenedione levels in serum after intervention [ng/ml]
    Time Frame
    12 weeks
    Title
    3. Anti-Müllerian hormone (AMH)
    Description
    Changes in AMH levels in serum after intervention [ng/ml]
    Time Frame
    12 weeks
    Title
    4. 17-Hydroxyprogesterone (17-OH-progesterone)
    Description
    Changes in 17-OH-progesterone levels in serum after intervention [ng/ml]
    Time Frame
    12 weeks
    Title
    5. Luteinizing hormone (LH)
    Description
    Changes in LH levels in serum after intervention [mU/ml]
    Time Frame
    12 weeks
    Title
    6. Follicle-stimulating hormone (FSH)
    Description
    Changes in FSH levels in serum after intervention [mU/ml]
    Time Frame
    12 weeks
    Title
    7. Insulin
    Description
    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
    Title
    8. Glucose
    Description
    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
    Title
    9. Matsuda index
    Description
    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
    Title
    10. Hirsutism
    Description
    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
    Title
    11. Body-mass-index (BMI)
    Description
    BMI measured with the formula BMI=weight [kg]/height² [m]
    Time Frame
    12 weeks
    Title
    12. waist-to-hip ratio
    Description
    Calculated with the formula: waist circumference/hip circumference
    Time Frame
    12 weeks
    Title
    13. Gut microbiome composition
    Description
    Changes in gut microbiome composition measured from stool samples via 16S-RNA gene sequencing
    Time Frame
    12 weeks
    Title
    14. Inflammatory markers
    Description
    Changes in inflammatory markers (Cytokines) measured by Human Cytokine/Chemokine/Growth Factor Panel A. 48 plex kit, pg/mL
    Time Frame
    12 weeks
    Title
    15. Untargeted metabolomics
    Description
    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
    Title
    16. Untargeted metabolomics
    Description
    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
    Title
    17. Serum Low-density lipoproteins (LDL)
    Description
    Changes in serum Low-density lipoproteins (LDL), mmol/L
    Time Frame
    12 weeks
    Title
    18. Serum high-density lipoproteins (LDL)
    Description
    Changes in serum high-density lipoproteins (LDL), mmol/L
    Time Frame
    12 weeks
    Title
    19. Serum triglyceride levels, mmol/L
    Description
    Changes in serum triglyceride levels, mmol/L
    Time Frame
    12 weeks
    Title
    20. Ovulation rate
    Description
    Percent of women with ovulation recorded by serial transvaginal ultrasound after 8 weeks of participating in the study
    Time Frame
    12 weeks
    Title
    21. Ovarian volume
    Description
    Changes in ovarian volume (cm3) measured by transvaginal ultrasound in early follicular phase or after 3 months of amenorrhea
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Polina Popova, MD,PhD
    Phone
    702-55-95
    Ext
    007(812)
    Email
    pvpopova@yandex.ru
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elena Vasiukova
    Email
    elenavasukova2@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Polina Popova, MD,PhD
    Organizational Affiliation
    Almazov National Medical Research Centre
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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