Recruiting

Increased Protein

Sponsor:

University of Arkansas, Fayetteville

Code:

NCT07158723

Conditions

Polycystic Ovary Syndrome (PCOS)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Higher protein dietary pattern

Calorie restriction

Study Details

Brief 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

Conditions

Polycystic Ovary Syndrome (PCOS)

Study ID

NCT07158723

Start date

Aug 1, 2025

Status verified date

Sep, 2025

Completion date

Dec 3, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Calorie restricted control

active comparator: Control and Protein

active comparator: Calorie restricted PCOS

active comparator: PCOS Protein

Interventions

Higher protein dietary pattern

Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein/kg body weight)

Calorie restriction

Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.

Primary outcome measure

  • Lean body mass [ Time Frame: 0 and 16 weeks. ]

Central Contacts and Locations

Locations

Center for Human Nutrition

Recruiting

Fayetteville, Arkansas, United States, 72704

Contacts

Sydney Boudrey, MS, RDN

seboudre@uark.edu

Principal Investigator:

Jamie I Baum, PhD

Center for Human Nutrition

Recruiting

Fayetteville, Arkansas, United States, 72704

Contacts

Sydney Boudrey, MS, RDN

seboudre@uark.edu

More Information

Sponsor

University of Arkansas, Fayetteville

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Keywords

  • PCOS
  • polycystic ovary syndrome
  • protein
  • women
  • wellbeing
  • metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas, Fayetteville on 2025-09-08.