Polycystic Ovary SyndromePCOSNCT06442189
The Results of the Mediterranean Diet for PCOS
An observational study of Polycystic Ovary Syndrome and Diet Habit, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Diet Habit
- What is being tested?
- Mediterranean Diet
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2024to 11 Nov 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: People receiving care at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital who have a body mass index of 25 or more and follow a Mediterranean diet will be included in the study group. 98 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing will be included in the study. The study was designed to be prospective. Data will be collected after 0 and 3 months.
Who may be able to join
- At the age of 18-40 years,
- No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),
- With a body mass index of 25 and above,
- Female patients attending the PCOS clinic and under the care of our hospital's dietitian will be enrolled in the study.
Who cannot join
- Age < 18 and > 40 years;
- Menopause, pregnancy or breastfeeding in the last 6 months;
- Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary etiologies, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction and adrenal disorders),
- Pre-existing systemic or psychiatric disease
- Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills, metformin, anti-epileptics, antipsychotics, statins and fish oil);
- Certain eating regimens or hypocaloric diet in the last three months; supplementing with antioxidants, vitamins or minerals;
- Non-steroidal anti-inflammatory drugs, diuretics, etc. use of medications that may affect fluid balance
- Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of interference with device activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Effects of the Mediterranean Diet on the Reproductive and Metabolic Parameters of Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) and a Body Mass Indexof Over 25 kg/m2
The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis.
Read the detailed description
Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD + PCOM group among these 4 different phenotype groups. The prevalence and distribution of metabolic abnormalities (insulin resistance, metabolic disease and glucose intolerance) among the phenotypes do not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not suitable to distinguish different clinical PCOS phenotypes. Some inflammatory cytokines are elevated in PCOS, which is characterized by chronic low-grade inflammation. Although the exact mechanisms of inflammation in PCOS are not yet fully understood, it is thought to be mediated by obesity, insulin resistance and high androgen levels. This inflammatory state has a negative impact on the risk of future health problems and quality of life in PCOS. Therefore, strategies to reduce inflammation are considered important. Establishing medical nutrition therapy for PCOS has significant implications for reducing this inflammation and preventing the disease. At this point, the Mediterranean diet, which has been shown to have a protective effect against many diseases, is receiving a lot of attention. Among the components of the Mediterranean diet, omega-3 fatty acids, antioxidants and fiber in particular can contribute to reducing inflammation through various mechanisms. The international scientific community has strongly emphasized the role of the Mediterranean diet and the lifestyle it inspires in increasing life expectancy and improving public health. For these reasons, the Mediterranean diet can be considered as a nutrient pool containing nutraceuticals and bioactive components in foods that can positively influence health both directly and through their own epigenetic mechanisms. Recent studies suggest that the Mediterranean diet can influence both the incidence and severity of PCOS and the treatment of the disease.
The main objective of our study is to evaluate the effect of the MedDiet, which is known to be anti-inflammatory and based on energy restriction and the Mediterranean dietary approach, on the reproductive and metabolic parameters of PCOS patients with a higher than normal body mass index.
- Conditions
- Polycystic Ovary Syndrome, Diet Habit
- Being tested
- Mediterranean Diet
- Keywords
- polycystic ovary syndrome, Mediterranean diet, obesity
- Medical subject headings
- Polycystic Ovary Syndrome, Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietDietary supplement
Also called Baseline, 3. Month
The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month of patients with a body mass index of 25 and more who were treated in our clinic due to a diagnosis of PCOS.
| Study group | Role | What they receive |
|---|---|---|
| 3. month | Once the baseline values have been determined at the first visit, all tests are repeated after the diet has been followed for 3 months. Receives: Dietary Supplement: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of applying a Mediterranean diet on Homa-IR in PCOS
Homeostasis model assessment (HoMA)-IR
Measured: 3 months
PREDIMED in PCOS
PREDIMED questionnaire
Measured: 3 months
the effect of applying a Mediterranean diet on glucose in PCOS
Fasting plasma glucose
Measured: 3 months
the effect of applying a Mediterranean diet on HbA1c in PCOS
HbA1c values
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start20 Sep 2024
- Primary completion7 Oct 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde Can Ibanoglu, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Mujde Can Ibanoglu, Principal investigator, Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442189
- Sponsor's protocol ID
- 01/06 22.01.2024
- Acronym
- PCOS
- Status last verified
- Nov 2024
- First submitted
- 18 May 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999 Jan;84(1):165-9. doi: 10.1210/jcem.84.1.5393.
PubMed 9920077Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.
PubMed 31547562
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Effects of the Mediterranean Diet on the Reproductive and Metabolic Parameters of Patients Diagnosed With Polycystic Ovary Syndrome (PCOS) and a Body Mass Indexof Over 25 kg/m2
- ClinicalTrials.gov ID
- NCT06442189
- Acronym / sponsor ID
- PCOS / 01/06 22.01.2024
- Conditions
- Polycystic Ovary Syndrome, Diet Habit
- Keywords
- polycystic ovary syndrome, Mediterranean diet, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 4 Jun 2024 (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.
The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis.
Detailed description
Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD + PCOM group among these 4 different phenotype groups. The prevalence and distribution of metabolic abnormalities (insulin resistance, metabolic disease and glucose intolerance) among the phenotypes do not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not suitable to distinguish different clinical PCOS phenotypes. Some inflammatory cytokines are elevated in PCOS, which is characterized by chronic low-grade inflammation. Although the exact mechanisms of inflammation in PCOS are not yet fully understood, it is thought to be mediated by obesity, insulin resistance and high androgen levels. This inflammatory state has a negative impact on the risk of future health problems and quality of life in PCOS. Therefore, strategies to reduce inflammation are considered important. Establishing medical nutrition therapy for PCOS has significant implications for reducing this inflammation and preventing the disease. At this point, the Mediterranean diet, which has been shown to have a protective effect against many diseases, is receiving a lot of attention. Among the components of the Mediterranean diet, omega-3 fatty acids, antioxidants and fiber in particular can contribute to reducing inflammation through various mechanisms. The international scientific community has strongly emphasized the role of the Mediterranean diet and the lifestyle it inspires in increasing life expectancy and improving public health. For these reasons, the Mediterranean diet can be considered as a nutrient pool containing nutraceuticals and bioactive components in foods that can positively influence health both directly and through their own epigenetic mechanisms. Recent studies suggest that the Mediterranean diet can influence both the incidence and severity of PCOS and the treatment of the disease.
The main objective of our study is to evaluate the effect of the MedDiet, which is known to be anti-inflammatory and based on energy restriction and the Mediterranean dietary approach, on the reproductive and metabolic parameters of PCOS patients with a higher than normal body mass index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3. month | – | Dietary Supplement: Mediterranean DietOnce the baseline values have been determined at the first visit, all tests are repeated after the diet has been followed for 3 months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People receiving care at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital who have a body mass index of 25 or more and follow a Mediterranean diet will be included in the study group. 98 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing will be included in the study. The study was designed to be prospective. Data will be collected after 0 and 3 months.
Key inclusion criteria (4 listed)
- At the age of 18-40 years,
- No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),
- With a body mass index of 25 and above,
- Female patients attending the PCOS clinic and under the care of our hospital's dietitian will be enrolled in the study.
Key exclusion criteria (8 listed)
- Age < 18 and > 40 years;
- Menopause, pregnancy or breastfeeding in the last 6 months;
- Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary etiologies, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction and adrenal disorders),
- Pre-existing systemic or psychiatric disease
- Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills, metformin, anti-epileptics, antipsychotics, statins and fish oil);
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 |
|---|---|---|
| Mediterranean DietAlso: Baseline, 3. MonthThe aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month of patients with a body mass index of 25 and more who were treated in our clinic due to a diagnosis of PCOS. | Dietary supplement | 3. month |
Primary outcome
the effect of applying a Mediterranean diet on Homa-IR in PCOS
Time frame: 3 months
Homeostasis model assessment (HoMA)-IR
PREDIMED in PCOS
Time frame: 3 months
PREDIMED questionnaire
the effect of applying a Mediterranean diet on glucose in PCOS
Time frame: 3 months
Fasting plasma glucose
the effect of applying a Mediterranean diet on HbA1c in PCOS
Time frame: 3 months
HbA1c values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Results publication: PubMed 9920077Legro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999 Jan;84(1):165-9. doi: 10.1210/jcem.84.1.5393.
- Results publication: PubMed 31547562Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.
- 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.
Mujde Can Ibanoglu principal investigator
Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Diet Habit, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of applying a Mediterranean diet on Homa-IR in PCOS (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442189, which also lists 2 linked publications.
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 19 Nov 2024.