Protein and Polycystic Ovary Syndrome (PCOS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-12-03

Brief Summary

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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

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome (PCOS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Calorie restricted control

Group Type ACTIVE_COMPARATOR

Calorie restriction

Intervention Type OTHER

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

Control and Protein

Group Type ACTIVE_COMPARATOR

Higher protein dietary pattern

Intervention Type OTHER

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

Calorie restricted PCOS

Group Type ACTIVE_COMPARATOR

Calorie restriction

Intervention Type OTHER

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

PCOS Protein

Group Type ACTIVE_COMPARATOR

Higher protein dietary pattern

Intervention Type OTHER

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

Interventions

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Higher protein dietary pattern

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

Intervention Type OTHER

Calorie restriction

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes