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RecruitingInterventional

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

NCT ID: NCT07158723Sponsor: University of Arkansas, FayettevilleLast updated: 2025-09-08

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

Arms & interventions

  • OtherHigher protein dietary pattern

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

  • OtherCalorie restriction

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

Outcome measures

Primary

  • Lean body mass

    Lean body mass will be measured using dual x-ray absorptiometry.

    Time frame: 0 and 16 weeks.

Secondary

  • Body fat mass

    Time frame: 0 and 16 weeks

  • Sleep Duration

    Time frame: Sleep will be measured every 8 weeks (0, 8, and 16 weeks)

  • Mood

    Time frame: Every 4 weeks (0, 4, 8, 12, 16 weeks)

  • Quality of Life perception

    Time frame: Every 4 weeks (0, 4, 8, 12, and 16 weeks)

  • Energy expenditure

    Time frame: Every 4 weeks (0, 4, 8, 12 and 16 weeks)

  • Plasma amino acid concentrations

    Time frame: Every 4 weeks (0, 4, 8, 12 and 16 weeks).

  • Inflammatory biomarkers

    Time frame: Every 4 weeks (0, 4, 8, 12, and 16 weeks).

  • Subjective Sleep Measurements

    Time frame: Subjective sleep will be measured at 0, 4, 8, 12, and 16 weeks.

Eligibility criteria

Sex: FemaleAge: 18 Years to 50 YearsHealthy volunteers: Yes
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 locations (2)

Center for Human Nutrition

Fayetteville, Arkansas, 72704

Recruiting
Jamie Baum, PhD · Contact
Sydney Boudrey, MS, RDN · Contact
Jamie I Baum, PhD · Principal Investigator

Center for Human Nutrition

Fayetteville, Arkansas, 72704

Recruiting
Jamie Baum, PhD · Contact
Sydney Boudrey, MS, RDN · Contact