Higher-protein diet for women with PCOS
Official title: Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)
Run by University of Arkansas, Fayetteville · NCT07158723 · Data updated 2026-11-12
This study will test whether a calorie-restricted diet with 30% of total energy from protein improves cardiometabolic health in women aged 18-50 who have PCOS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of Arkansas, Fayetteville Academic / other |
| Locations | 2 sites (Fayetteville, Arkansas and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | December 3, 2027 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT07158723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–50 with a confirmed PCOS diagnosis, BMI 18.5–35 kg/m2, stable weight for at least three months, and willingness to consume both plant- and animal-based protein are ideal candidates.
✕Probably not a fit
Women with diagnosed diabetes, on metabolic medications such as metformin or GLP-1 agonists, with incompatible food allergies or dietary restrictions, current smokers, or those already consuming high-protein diets are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll adult women with confirmed PCOS and BMI 18.5–35 kg/m2 and place them on a calorie-restricted dietary program that sets protein at 30% of total energy and includes both plant- and animal-based meals. Eligible participants must have stable body weight for at least three months and not be taking medications that interfere with metabolic outcomes. The protocol will compare cardiometabolic measures such as insulin resistance, body composition, and cardiovascular risk markers before and after the dietary intervention. All study procedures and visits take place at the Center for Human Nutrition in Fayetteville, Arkansas.
Why it matters
Potential benefit: If successful, a higher-protein, calorie-restricted diet could improve insulin sensitivity, body composition, and long-term cardiometabolic risk for women with PCOS.
How similar studies have gone: Prior studies have linked higher protein intake to improved energy balance, muscle maintenance, and cardiometabolic markers in broader populations, but controlled trials specifically targeting women with PCOS are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Center for Human Nutrition
Fayetteville, Arkansas, United States Recruiting -
Center for Human Nutrition
Fayetteville, Arkansas, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.