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
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
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
NCT ID
NCT05272657
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
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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Low-Carb Versus Mediterranean Diet in PCOS
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