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Clinical Trial Summary

The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.


Clinical Trial Description

After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle. Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose. Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction. After data collection, statistical analyses was done to determine the effect of the different approaches. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06031753
Study type Interventional
Source Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento
Contact
Status Completed
Phase N/A
Start date June 3, 2021
Completion date October 11, 2022

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