EICHORCondition: Polycystic Ovary Syndrome (PCOS) · Sponsor: University of Arkansas, Fayetteville
Interested? Contact the study team ↓
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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 neu…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Center for Human Nutrition | Fayetteville, Arkansas, United States | Recruiting |
| Center for Human Nutrition | Fayetteville, Arkansas, United States | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07158723