Protein and Polycystic Ovary Syndrome (PCOS)

NCT07158723 | Recruiting

• 1 other identifier: 2503592283
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Lean body mass

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

  0 and 16 weeks.

Secondary Outcomes (8)

• Body fat mass

  0 and 16 weeks

• Sleep Duration

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

• Mood

  Every 4 weeks (0, 4, 8, 12, 16 weeks)

• Quality of Life perception

  Every 4 weeks (0, 4, 8, 12, and 16 weeks)

• Energy expenditure

  Every 4 weeks (0, 4, 8, 12 and 16 weeks)

Study Arms (4)

Calorie restricted control

ACTIVE COMPARATOR

Other: Calorie restriction

Control and Protein

ACTIVE COMPARATOR

Other: Higher protein dietary pattern

Calorie restricted PCOS

ACTIVE COMPARATOR

Other: Calorie restriction

PCOS Protein

ACTIVE COMPARATOR

Other: Higher protein dietary pattern

Interventions

Higher protein dietary pattern OTHER

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

Control and Protein; PCOS Protein

Calorie restriction OTHER

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

Calorie restricted PCOS; Calorie restricted control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead
• Arkansas Biosciences Institute: collaborator

Study Sites (2)

Center for Human Nutrition

Fayetteville, Arkansas, 72704, United States

RECRUITING

Center for Human Nutrition

Fayetteville, Arkansas, 72704, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 3, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (2)