- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07142603
- Original Trial
Appetite Response to Meals With Different Protein Sources in Women With PCOS
Comparative Meal Response to Plant vs. Animal Protein in Women With PCOS
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jamie I Baum, PhD
- Phone Number: 479-575-4474
- Email: baum@uark.edu
Study Contact Backup
- Name: Sydney Boudrey, MS, RDN
- Email: seboudre@uark.edu
Study Locations
-
-
Arkansas
-
Fayetteville, Arkansas, United States, 72704
- Recruiting
- Center for Human Nutrition
-
Contact:
- Jamie I Baum, PhD
- Phone Number: 479-575-4474
- Email: baum@uark.edu
-
Principal Investigator:
- Jamie I Baum, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy expenditure
Time Frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma amino acid response
Time Frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
Plasma amino acids will be measured using UPLC
|
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
|
Appetite
Time Frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
Participants will be asked to rate their perceived hunger, fullness, and desire to eat with the use of a traditional 100 mm visual analog scales (VAS) with opposing anchors (e.g., "extremely hungry" or "not hungry at all").
The questions include "how hungry do you feel at this moment," "how full do you feel at this moment," "how strong is your desire to eat at this moment," and "how much food do you think you could eat at this moment."
Participants will also be asked to evaluate the appearance ("how much do you like or dislike the appearance of the breakfast foods") and palatability ("how much do you like or dislike the smell and taste of the breakfast foods") of the breakfast with the use of a traditional 100 mm visual analog scale with opposing anchors "dislike extremely" or "like extremely."
Appetite assessments were measured at 0, 15, 30, 60, 120, and 240 min after the meal.
|
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
|
Plasma biomarkers related to appetite
Time Frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
Appetite biomarkers including PYY (Peptide YY), CCK (cholecystokinin), BDNF (brain-derived neurotrophic factor), GLP-1 (glucagon-like petide-1), and ghrelin will be measured using commercially available kits.
This measurements will be interpreted together to make a conclusion about a appetite regulation in response to protein source.
|
Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jamie I Baum, PhD, University of Arkansas, Fayetteville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2507614944
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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