Actively Recruiting
Protein and Polycystic Ovary Syndrome (PCOS)
Led by University of Arkansas, Fayetteville · Updated on 2025-09-08
60
Participants Needed
2
Research Sites
122 weeks
Total Duration
On this page
Sponsors
U
University of Arkansas, Fayetteville
Lead Sponsor
A
Arkansas Biosciences Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Protein and Polycystic Ovary Syndrome (PCOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 50 years
- Confirmed diagnosis of Polycystic Ovary Syndrome (PCOS)
- Body mass index (BMI) between 18.5 and 35 kg/m2
- Stable body weight for at least 3 months within plus or minus 5 pounds
- Willingness to consume both plant- and animal-based protein meals
You will not qualify if you...
- Smoking or use of nicotine products
- Smoking, vaping, or use of marijuana products
- Consuming more than 4 alcoholic beverages per week
- Food allergies or dietary restrictions incompatible with study meals
- Diagnosed diabetes (type 1 or type 2) or other chronic diseases
- Use of medications affecting study outcomes (e.g., metformin, GLP-1 agonists)
- Consuming more than 0.8 grams of protein per kilogram of body weight
- Being underweight
- Taking nutritional supplements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Center for Human Nutrition
Fayetteville, Arkansas, United States, 72704
Actively Recruiting
2
Center for Human Nutrition
Fayetteville, Arkansas, United States, 72704
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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