Viewing Study NCT06442189



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06442189
Status: RECRUITING
Last Update Posted: 2024-06-04
First Post: 2024-05-18

Brief Title: The Results of the Mediterranean Diet for PCOS
Sponsor: Etlik Zubeyde Hanım Womens Health Care Training and Research Hospital
Organization: Etlik Zubeyde Hanım Womens Health Care Training and Research Hospital

Study Overview

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 kgm2
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PCOS
Brief 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
Detailed Description: Polycystic ovary syndrome PCOS is an endocrine-metabolic disorder characterized by menstrual irregularities anovulation clinical andor biochemical symptoms of hyperandrogenism hirsutism andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None