RecruitingNot ApplicableNCT07158723

Protein and Polycystic Ovary Syndrome (PCOS)

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


Sponsor

University of Arkansas, Fayetteville

Enrollment

60 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how different types of protein — plant-based vs. animal-based — affect hormone levels and metabolic function in women with Polycystic Ovary Syndrome (PCOS), a hormonal condition that affects periods, fertility, and metabolism. **You may be eligible if...** - You are a woman between 18 and 50 years old - You have a confirmed diagnosis of PCOS - Your BMI is between 18.5 and 35 kg/m² - Your weight has been stable for at least 3 months - You are willing to eat both plant- and animal-based protein meals **You may NOT be eligible if...** - You smoke or use nicotine or marijuana products - You drink more than 4 alcoholic beverages per week - You have food allergies or dietary restrictions that prevent you from eating the study meals - You have diabetes or another serious chronic illness - You currently take medications that could interfere with results (e.g., metformin, GLP-1 drugs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHigher protein dietary pattern

Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein/kg body weight)

OTHERCalorie restriction

Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.


Locations(2)

Center for Human Nutrition

Fayetteville, Arkansas, United States

Center for Human Nutrition

Fayetteville, Arkansas, United States

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NCT07158723


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