Protein and Polycystic Ovary Syndrome (PCOS)

Conditions

• Polycystic Ovary Syndrome (PCOS)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Higher protein dietary pattern — OTHER
  Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein/kg body weight)
• Calorie restriction — OTHER
  Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.

Study Details

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

Key Dates

Start date

Aug 1, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2027

Completion

Dec 3, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Calorie restricted control
• Active Comparator: Control and Protein
• Active Comparator: Calorie restricted PCOS
• Active Comparator: PCOS Protein

Primary Outcome Measure

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

Locations (2)

Find similar trials in Fayetteville, AR

Related Studies

• Appetite Response to Meals With Different Protein Sources in Women With PCOS
  Recruiting · University of Arkansas, Fayetteville · Fayetteville, Arkansas