Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
NCT07158723

Protein and Polycystic Ovary Syndrome (PCOS)

Led by University of Arkansas, Fayetteville · Updated on 2025-09-08

60

Participants Needed

2

Research Sites

122 weeks

Total Duration

On this page

Sponsors

U

University of Arkansas, Fayetteville

Lead Sponsor

A

Arkansas Biosciences Institute

Collaborating Sponsor

AI-Summary

What this Trial 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., 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

CONDITIONS

Official Title

Protein and Polycystic Ovary Syndrome (PCOS)

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 50 years
  • Confirmed diagnosis of Polycystic Ovary Syndrome (PCOS)
  • Body mass index (BMI) between 18.5 and 35 kg/m2
  • Stable body weight for at least 3 months within plus or minus 5 pounds
  • Willingness to consume both plant- and animal-based protein meals
Not Eligible

You will not qualify if you...

  • Smoking or use of nicotine products
  • Smoking, vaping, or use of marijuana products
  • Consuming more than 4 alcoholic beverages per week
  • Food allergies or dietary restrictions incompatible with study meals
  • Diagnosed diabetes (type 1 or type 2) or other chronic diseases
  • Use of medications affecting study outcomes (e.g., metformin, GLP-1 agonists)
  • Consuming more than 0.8 grams of protein per kilogram of body weight
  • Being underweight
  • Taking nutritional supplements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Center for Human Nutrition

Fayetteville, Arkansas, United States, 72704

Actively Recruiting

2

Center for Human Nutrition

Fayetteville, Arkansas, United States, 72704

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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