Protein and Polycystic Ovary Syndrome (PCOS)

Recruiting now · Not applicable

Conditions studied: Polycystic Ovary Syndrome (PCOS)

In brief

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

Key facts

Study ID: NCT07158723
Run by: University of Arkansas, Fayetteville
People needed: 60
Starts: 2025-08-01
Expected to finish: 2027-12-03
Last updated by the study team: 2025-09-08

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Females ages 18-50 years
Confirmed diagnosis of PCOS
Body mass index (BMI) between 18.5 and 35 kg/m2
Stable body weight for at least 3 months (+ 5 pounds)
Willingness to consume both plant- and animal-based protein meals

You may not qualify if…

Smoking or use of nicotine products
Smoking, vaping, and/or use of marijuana products
More than 4 alcoholic beverages per week
Food allergies or dietary restrictions incompatible with test meals
Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s).
Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)
Consumption of more than 0.8 g/protein/kg body weight
Underweight
Taking nutritional supplements

Where it is running

Center for Human Nutrition — Fayetteville, Arkansas, United States (enrolling)
Center for Human Nutrition — Fayetteville, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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