NCT07158723 · University of Arkansas, Fayetteville
Protein and Polycystic Ovary Syndrome (PCOS)
What this study 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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Fayetteville, Arkansas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 8, 2025 · Source of record for eligibility and locations