Polycystic Ovary Syndrome (PCOS)NCT05272657
Low-Carb Versus Mediterranean Diet in PCOS
A study testing low-carbohydrate diet and Mediterranean diet in people with Polycystic Ovary Syndrome (PCOS), run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health.
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 . Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- low-carbohydrate diet and Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- Adrenal glands
- Metabolism of carbohydrates
- Lipids
- Microbiota composition during the 2 months preceding the study
- Pregnancy
- Lactation
- Significant comorbidities
Trial locations and contacts
No sites are listed yet.
Elena Vasiukova contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- low-carbohydrate diet, Mediterranean diet
- Keywords
- microbiome, obesity, Mediterranean diet, low-carb diet
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-carbohydrate dietOther
subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
Mediterranean dietOther
subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| low-carbohydrate diet | Experimental | subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet. Receives: Other: low-carbohydrate diet |
| Mediterranean diet | Experimental | subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet. Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
2. Free androgen index
Changes in free androgen index [ (total testosterone level / sex hormone binding globulin (SHBG) level) * 100].
Measured: 12 weeks
Secondary outcomes (21)
1. Total testosterone
Changes in total testosterone levels [nmol/L] in serum after intervention
Measured: 12 weeks
2. Androstenedione
Changes in androstenedione levels in serum after intervention [ng/ml]
Measured: 12 weeks
3. Anti-Müllerian hormone (AMH)
Changes in AMH levels in serum after intervention [ng/ml]
Measured: 12 weeks
4. 17-Hydroxyprogesterone (17-OH-progesterone)
Changes in 17-OH-progesterone levels in serum after intervention [ng/ml]
Measured: 12 weeks
5. Luteinizing hormone (LH)
Changes in LH levels in serum after intervention [mU/ml]
Measured: 12 weeks
6. Follicle-stimulating hormone (FSH)
Changes in FSH levels in serum after intervention [mU/ml]
Measured: 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]
Measured: 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]
Measured: 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)
Measured: 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
Measured: 12 weeks
11. Body-mass-index (BMI)
BMI measured with the formula BMI=weight [kg]/height² [m]
Measured: 12 weeks
12. waist-to-hip ratio
Calculated with the formula: waist circumference/hip circumference
Measured: 12 weeks
13. Gut microbiome composition
Changes in gut microbiome composition measured from stool samples via 16S-RNA gene sequencing
Measured: 12 weeks
14. Inflammatory markers
Changes in inflammatory markers (Cytokines) measured by Human Cytokine/Chemokine/Growth Factor Panel A. 48 plex kit, pg/mL
Measured: 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).
Measured: 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).
Measured: 12 weeks
17. Serum Low-density lipoproteins (LDL)
Changes in serum Low-density lipoproteins (LDL), mmol/L
Measured: 12 weeks
18. Serum high-density lipoproteins (LDL)
Changes in serum high-density lipoproteins (LDL), mmol/L
Measured: 12 weeks
19. Serum triglyceride levels, mmol/L
Changes in serum triglyceride levels, mmol/L
Measured: 12 weeks
20. Ovulation rate
Percent of women with ovulation recorded by serial transvaginal ultrasound after 8 weeks of participating in the study
Measured: 12 weeks
21. Ovarian volume
Changes in ovarian volume (cm3) measured by transvaginal ultrasound in early follicular phase or after 3 months of amenorrhea
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start30 Mar 2022 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Polina Popova, MD,PhD, Study chair, Almazov National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272657
- Sponsor's protocol ID
- Pcos2typesofDiet
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Carbohydrate Diet Versus Mediterranean Diet as Treatment for Women With Polycystic Ovary Syndrome.
- ClinicalTrials.gov ID
- NCT05272657
- Acronym / sponsor ID
- Pcos2typesofDiet
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- microbiome, obesity, Mediterranean diet, low-carb diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 30 Mar 2022 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-carbohydrate diet | Experimental | Other: low-carbohydrate dietsubjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet. |
| Mediterranean diet | Experimental | Other: Mediterranean dietsubjects in this arm are given detailed instructions and coaching in following a Mediterranean diet. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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):
Key exclusion criteria (13 listed)
- The presence of hyperprolactinemia
- Cushing's syndrome
- Ongenital hyperplasia of the adrenal cortex
- Hypothyroidism
- Androgen-producing tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-carbohydrate dietsubjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet. | Other | low-carbohydrate diet |
| Mediterranean dietsubjects in this arm are given detailed instructions and coaching in following a Mediterranean diet. | Other | Mediterranean diet |
Primary outcome
1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index
Time frame: 12 weeks
Changes in HOMA-IR index (fasting insulin [mU/l] * fasting glucose [mmol/L]/22.5) after intervention
2. Free androgen index
Time frame: 12 weeks
Changes in free androgen index [ (total testosterone level / sex hormone binding globulin (SHBG) level) * 100].
21 secondary outcomes
1. Total testosterone
Time frame: 12 weeks
2. Androstenedione
Time frame: 12 weeks
3. Anti-Müllerian hormone (AMH)
Time frame: 12 weeks
4. 17-Hydroxyprogesterone (17-OH-progesterone)
Time frame: 12 weeks
5. Luteinizing hormone (LH)
Time frame: 12 weeks
6. Follicle-stimulating hormone (FSH)
Time frame: 12 weeks
7. Insulin
Time frame: 12 weeks
8. Glucose
Time frame: 12 weeks
9. Matsuda index
Time frame: 12 weeks
10. Hirsutism
Time frame: 12 weeks
11. Body-mass-index (BMI)
Time frame: 12 weeks
12. waist-to-hip ratio
Time frame: 12 weeks
13. Gut microbiome composition
Time frame: 12 weeks
14. Inflammatory markers
Time frame: 12 weeks
15. Untargeted metabolomics
Time frame: 12 weeks
16. Untargeted metabolomics
Time frame: 12 weeks
17. Serum Low-density lipoproteins (LDL)
Time frame: 12 weeks
18. Serum high-density lipoproteins (LDL)
Time frame: 12 weeks
19. Serum triglyceride levels, mmol/L
Time frame: 12 weeks
20. Ovulation rate
Time frame: 12 weeks
21. Ovarian volume
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Vasiukova contact
Polina Popova, MD,PhD study chair
Almazov National Medical Research Centre
Questions about this trial
What is this clinical trial studying?
A study testing low-carbohydrate diet and Mediterranean diet in people with Polycystic Ovary Syndrome (PCOS), run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polina Popova, MD,PhD (702-55-95 ext. 007(812), pvpopova@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.