NCT07158723Recruiting
Protein and Polycystic Ovary Syndrome (PCOS)
Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- University of Arkansas, Fayetteville
- NCT number
- NCT07158723
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Aug 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)
Other illness
- Food allergies or dietary restrictions incompatible with test meals
- Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s).
Other
- Smoking or use of nicotine products
- Smoking, vaping, and/or use of marijuana products
- More than 4 alcoholic beverages per week
- Consumption of more than 0.8 g/protein/kg body weight
- Underweight
- Taking nutritional supplements
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Human Nutrition Coordinator of this site? Confirm its status | Fayetteville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.