NCT07158723

Protein and Polycystic Ovary Syndrome (PCOS)

Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Arkansas, Fayetteville · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified. There is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and/or changes in cortisol, energy metabolism, inflammation, and neurological regulators

Conditions

• Polycystic Ovary Syndrome (PCOS)

Interventions

Type	Name	Description
OTHER	Higher protein dietary pattern	Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein/kg body weight)
OTHER	Calorie restriction	Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-06-30
• Completion: 2027-12-03
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

2 sites across 1 country: United States