Recruiting

Plant & Animal Protein

Sponsor:

University of Arkansas, Fayetteville

Code:

NCT07142603

Conditions

Polycystic Ovary Syndrome (PCOS)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Metabolic response to protein source

Study Details

Brief summary:

Polycystic ovary syndrome (PCOS) is a common endocrine disorder characterized by insulin resistance, hyperandrogenism, and reproductive dysfunction. Dietary strategies that improve postprandial insulin and glucose responses are central to managing metabolic symptoms in PCOS.

Meals higher in protein can attenuate postprandial glycemia and enhance satiety, but the effects may vary by protein source. Animal sources of protein typically have higher essential amino acid content and insulinogenic potential, whereas plant proteins offer fiber and phytochemicals that may influence glycemic dynamics differently. Few studies have directly compared the acute metabolic effects of plant versus animal protein in women with PCOS. Given the distinct pathophysiology of PCOS, extrapolating findings from healthy populations may be misleading.

Understanding protein-specific effects on postprandial insulin, glucose, and appetite-regulating hormones in this group is essential for targeted nutrition guidance. Additionally, plant-based diets are increasingly promoted for cardiometabolic health, but their acute effects in insulin-resistant women remain underexplored. This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary recommendations aimed at improving metabolic outcomes in this high-risk population.

Conditions

Polycystic Ovary Syndrome (PCOS)

Study ID

NCT07142603

Start date

Aug 18, 2025

Status verified date

Aug, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 or use of marijuana products
  • Food allergies or dietary restrictions incompatible with test meals
  • Diagnosed diabetes (type 1 or 2)
  • Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Plant protein challenge

After an overnight fast, participants will be given a 350-400 kcal meal containing 30% energy from plant protein sources. Participants will be given 10 minutes to consume the meal and appetite and metabolic response will be measured for 240 following the meal.

experimental: Animal Protein Challenge

After an overnight fast, participants will be given a 350-400 kcal meal containing 30% energy from animal protein sources. Participants will be given 10 minutes to consume the meal and appetite and metabolic response will be measured for 240 following the meal.

Interventions

Metabolic response to protein source

Participants will be given a 350-400 kcal meal challenge containing 30% energy from animal protein. They will be given 10 minutes to consume the meal and meal response will be measured 240 minutes following the meal.

Primary outcome measure

  • Energy expenditure [ Time Frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge). ]

Central Contacts and Locations

Central contacts

Sydney Boudrey, MS, RDN

seboudre@uark.edu

Locations

Center for Human Nutrition

Recruiting

Fayetteville, Arkansas, United States, 72704

Contacts

Principal Investigator:

Jamie I Baum, PhD

More Information

Sponsor

University of Arkansas, Fayetteville

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

  • PCOS
  • polycystic ovary syndrome
  • Protein
  • Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas, Fayetteville on 2025-09-02.