Title of project

RESTORE-PCOS: Targeting insulin REsiSTance and Ovulatory dysfunction through pRE-meal whey protein in PCOS: A 12-week Randomized Controlled Trial

Abstract

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 18% of women and characterized by insulin resistance, hyperandrogenism, and ovulatory dysfunction leading to health issues like infertility, cardiovascular disease, type 2 diabetes, and adverse pregnancy outcomes. Current pharmacological treatments, such as metformin or oral contraceptives, can be effective but are unsuitable for women planning pregnancy or those seeking non-drug options. This highlights the need for safe, accessible, and lifestyle-based interventions.

Dietary strategies that enhance insulin sensitivity are particularly relevant. Pre-meal whey protein has been shown to improve postprandial glucose control in insulin-resistant populations, but its effects in PCOS remain poorly studied. Existing research is limited to acute outcomes and lacks rigorous assessment using gold-standard measures of insulin sensitivity. The long-term potential of whey protein as a simple nutritional intervention for women with PCOS is therefore unknown – representing an important gap this project aims to address.

This project comprises two studies. Study 1 will involve women with PCOS to assess the palatability and acceptability of different whey protein formulations, ensuring the intervention is patient-centered and feasible. Study 2 is a 12-week double-blinded randomized controlled trial investigating the acute and chronic effects of pre-meal whey protein supplementation on insulin sensitivity, ovulatory frequency, body composition, androgen profiles, inflammation, and patient-reported outcomes. The primary endpoint is the change in insulin sensitivity measured by the hyperinsulinemic-euglycemic clamp (gold standard methodology). Secondary endpoints include reproductive hormones, menstrual regularity, metabolic markers, and quality of life.

This interdisciplinary project combines clinical endocrinology, nutrition science, metabolism, and food technology in close collaboration with Arla Foods Ingredients, which will contribute formulation expertise and host the postdoctoral researcher in a translational R&D environment. This academic-industrial collaboration with Arla Foods Ingredients translates nutritional science into a feasible intervention with clinical potential. A research stay at the University of Galway under Professor Fidelma Dunne and Dr. Christine Newman is also included in the project and will further strengthen international collaboration and methodological expertise.

The project addresses significant knowledge gaps in women’s metabolic health and has the potential to deliver evidence-based, non-pharmaceutical interventions that improve insulin sensitivity and reproductive function in women with PCOS.