Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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

Locations
United States
Arkansas
Center for Human Nutrition
RECRUITING
Fayetteville
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-12-03
Participants
Target number of participants: 60
Treatments
Active_comparator: Calorie restricted control
Active_comparator: Control and Protein
Active_comparator: Calorie restricted PCOS
Active_comparator: PCOS Protein
Sponsors
Leads: University of Arkansas, Fayetteville
Collaborators: Arkansas Biosciences Institute

This content was sourced from clinicaltrials.gov