Appetite Response to Meals With Different Protein Sources in Women With PCOS

NCT07142603 | Recruiting

• 1 other identifier: 2507614944
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

PCOS; polycystic ovary syndrome; Protein; Women

Outcome Measures

Primary Outcomes (1)

• Energy expenditure

  Energy expenditure will be measured using indirect calorimetry.

  Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

Secondary Outcomes (3)

• Appetite

  Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

• Plasma amino acid response

  Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

• Plasma biomarkers related to appetite

  Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).

Study Arms (2)

Plant protein challenge

ACTIVE COMPARATOR

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.

Other: Metabolic response to protein source

Animal Protein Challenge

EXPERIMENTAL

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.

Other: Metabolic response to protein source

Interventions

Metabolic response to protein source OTHER

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.

Animal Protein Challenge; Plant protein challenge

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• 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 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.)

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead

Study Sites (1)

Center for Human Nutrition

Fayetteville, Arkansas, 72704, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

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

Study Officials

• Jamie I Baum, PhD

  University of Arkansas, Fayetteville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie I Baum, PhD

CONTACT

479-575-4474; baum@uark.edu

Sydney Boudrey, MS, RDN

CONTACT

seboudre@uark.edu

Study Design

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

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)