NCT05272657

Low-Carb Versus Mediterranean Diet in PCOS

Low-Carbohydrate Diet Versus Mediterranean Diet as Treatment for Women With Polycystic Ovary Syndrome.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.

Detailed description

The study aims to clarify the impact of nutritional recommendations for women with polycystic ovary syndrome on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . Women with PCOS are randomized into 2 treatment groups: one group on a low-carbohydrate diet and the other on a Mediterranean diet. The adhearance to a prescribed diet will be controlled through food intake diaries using a mobile application with electronic reporting forms.

Conditions

• Polycystic Ovary Syndrome (PCOS)

Interventions

Type	Name	Description
OTHER	low-carbohydrate diet	subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.
OTHER	Mediterranean diet	subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.

Timeline

• Start date: 2022-03-30
• Primary completion: 2024-03-30
• Completion: 2024-06-30
• First posted: 2022-03-09
• Last updated: 2022-04-01