Testing a higher-protein diet for metabolic health in women with PCOS
Tests a higher-protein diet with calorie restriction in women with polycystic ovary syndrome.
Key facts
- Who runs it
- University of Arkansas, Fayetteville
- Where
- Fayetteville, United StatesSee the site
- Trial code
- Registry title
- Protein and Polycystic Ovary Syndrome (PCOS)
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 1 Aug 2025
- Expected to end
- 3 Dec 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Higher protein dietary pattern
- Calorie restriction
- Record updated
- 8 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 50 with a confirmed diagnosis of polycystic ovary syndrome (PCOS) who are willing to eat both plant- and animal-based protein meals.
- Age
- 18 to 50 years
- Sex
- Women only
- Disease stage
- Confirmed diagnosis of PCOS. Body mass index (BMI) between 18.5 and 35 kg/m2.
- Earlier treatment
- Stable body weight for at least 3 months (+ 5 pounds (2 kg)). Cannot take medicines that interfere with study results, such as metformin or GLP-1 agonists. Cannot take nutritional supplements.
Main reasons for not taking part
- Smoking, vaping, nicotine or marijuana use
- More than 4 alcoholic drinks per week
- Diagnosed diabetes (type 1 or 2) or another existing chronic disease
- Food allergies or dietary restrictions that do not fit the test meals
- Eating more than 0.8 g protein per kg body weight, or being underweight
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)
- Food allergies or dietary restrictions incompatible with test meals
- Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s)
- Smoking or use of nicotine products
- Smoking, vaping, and/or use of marijuana products
- More than 4 alcoholic beverages per week
- Consumption of more than 0.8 g/protein/kg body weight
- Underweight
- Taking nutritional supplements
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- Center for Human NutritionFayetteville, United StatesContact: Jamie Baum, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 4 groups in the trial
- Calorie restricted controlExisting treatment, for comparison
Treatment: Calorie restriction
- Control and ProteinExisting treatment, for comparison
Treatment: Higher protein dietary pattern
- Calorie restricted PCOSExisting treatment, for comparison
Treatment: Calorie restriction
- PCOS ProteinExisting treatment, for comparison
Treatment: Higher protein dietary pattern
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)
- Plain-language title
- Testing a higher-protein diet for metabolic health in women with PCOSGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07158723, who can take part
- Record updated
- 8 September 2025