Protein and Polycystic Ovary Syndrome (PCOS)

Last updated: September 2, 2025
Sponsor: University of Arkansas, Fayetteville
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Female Hormonal Deficiencies/abnormalities

Treatment

Calorie restriction

Higher protein dietary pattern

Clinical Study ID

NCT07158723
2503592283
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

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-1agonists, etc.)

  • Consumption of more than 0.8 g/protein/kg body weight

  • Underweight

  • Taking nutritional supplements

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Calorie restriction
Phase:
Study Start date:
August 01, 2025
Estimated Completion Date:
December 03, 2027

Connect with a study center

  • Center for Human Nutrition

    Fayetteville 4110486, Arkansas 4099753 72704
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.