Protein and Polycystic Ovary Syndrome (PCOS)

University of Arkansas, Fayetteville

Status: Enrolling

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Other: Calorie restriction; Other: Higher protein dietary pattern

Study type: Interventional

Funder types: Other

Identifiers

NCT07158723

2503592283

Details and patient eligibility

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Calorie restricted control

Active Comparator group

Treatment:

Other: Calorie restriction

Control and Protein

Active Comparator group

Treatment:

Other: Higher protein dietary pattern

Calorie restricted PCOS

Active Comparator group

Treatment:

Other: Calorie restriction

PCOS Protein

Active Comparator group

Treatment:

Other: Higher protein dietary pattern