The Results of the Mediterranean Diet for PCOS

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442189
• Other study ID #: 01/06 22.01.2024
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: June 2024
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Contact: Mujde Can Ibanoglu
• Phone: 05323089488
• Email: Drmujdecan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: September 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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:

1. Age < 18 and > 40 years;

2. Menopause, pregnancy or breastfeeding in the last 6 months;

3. 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),

4. Pre-existing systemic or psychiatric disease

5. Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills, metformin, anti-epileptics, antipsychotics, statins and fish oil);

6. Certain eating regimens or hypocaloric diet in the last three months; supplementing with antioxidants, vitamins or minerals;

7. Non-steroidal anti-inflammatory drugs, diuretics, etc. use of medications that may affect fluid balance

8. Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of interference with device activity.

Related Conditions & MeSH terms

• Diet Habit
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Mediterranean Diet
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

References & Publications (2)

Barrea 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(1 — View Citation

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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effect of applying a Mediterranean diet on Homa-IR in PCOS	Homeostasis model assessment (HoMA)-IR	3 months
Primary	PREDIMED in PCOS	PREDIMED questionnaire	3 months
Primary	the effect of applying a Mediterranean diet on glucose in PCOS	Fasting plasma glucose	3 months
Primary	the effect of applying a Mediterranean diet on HbA1c in PCOS	HbA1c values	3 months