Protein and Polycystic Ovary Syndrome (PCOS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Higher protein dietary pattern, Calorie restriction.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome (PCOS). Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)
Overview
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
Interventions
- Other Higher protein dietary pattern
Follow energy-restricted (10% calorie reduction), higher protein dietary pattern (1.6 g protein/kg body weight) - Other Calorie restriction
Follow energy-restricted (10% calorie reduction) dietary pattern for 16 weeks. No restrictions on macronutrient content.
Primary outcome measures
- Lean body mass [Time frame: 0 and 16 weeks.]
Secondary outcome measures (8)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Center for Human Nutrition — Fayetteville
- Center for Human Nutrition — Fayetteville
Identifiers
NCT: NCT07158723 · 2503592283