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Completed

NCT Number: NCT06442189

The Results of the Mediterranean Diet for PCOS

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mediterranean diet

Dietary Supplement

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.

Other names: Baseline, 3. Month

Primary outcomes

  1. the effect of applying a Mediterranean diet on Homa-IR in PCOS

    Time frame: 3 months

    Homeostasis model assessment (HoMA)-IR

  2. PREDIMED in PCOS

    Time frame: 3 months

    PREDIMED questionnaire

  3. the effect of applying a Mediterranean diet on glucose in PCOS

    Time frame: 3 months

    Fasting plasma glucose

  4. the effect of applying a Mediterranean diet on HbA1c in PCOS

    Time frame: 3 months

    HbA1c values

Sponsors and collaborators

Lead sponsor

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Other

Registry information

Official study 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

Acronym: PCOS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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