Polycystic Ovary Syndrome (PCOS)NCT07142603
Appetite Response to Meals With Different Protein Sources in Women With PCOS
A study testing Metabolic response to protein source in people with Polycystic Ovary Syndrome (PCOS), run by University of Arkansas, Fayetteville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Metabolic response to protein source
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sydney Boudrey, MS, RDN contact
United States1 site, 1 recruiting
- Recruiting
Center for Human Nutrition
Fayetteville, Arkansas, 72704
Jamie I Baum, PhD, 479-575-4474, baum@uark.edu
Jamie I Baum, PhD
About this study
Official title: 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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Metabolic response to protein source
- Keywords
- PCOS, polycystic ovary syndrome, Protein, Women
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic response to protein sourceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Metabolic response to protein source |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Energy expenditure will be measured using indirect calorimetry.
Measured: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
Secondary outcomes (3)
Appetite
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.
Measured: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
Plasma amino acid response
Plasma amino acids will be measured using UPLC
Measured: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
Plasma biomarkers related to appetite
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.
Measured: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start18 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie I Baum, PhD, Principal investigator, University of Arkansas, Fayetteville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142603
- Sponsor's protocol ID
- 2507614944
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Meal Response to Plant vs. Animal Protein in Women With PCOS
- ClinicalTrials.gov ID
- NCT07142603
- Acronym / sponsor ID
- 2507614944
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- PCOS, polycystic ovary syndrome, Protein, Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant protein challenge | Active comparator | Other: Metabolic response to protein sourceAfter 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. |
| Animal Protein Challenge | Experimental | Other: Metabolic response to protein sourceAfter 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic response to protein sourceParticipants 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. | Other | Animal Protein Challenge, Plant protein challenge |
Primary outcome
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.
3 secondary outcomes
Appetite
Time frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).
Plasma amino acid response
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sydney Boudrey, MS, RDN contact
Jamie I Baum, PhD principal investigator
University of Arkansas, Fayetteville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic response to protein source in people with Polycystic Ovary Syndrome (PCOS), run by University of Arkansas, Fayetteville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie I Baum, PhD (479-575-4474, baum@uark.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: Meal response over 240 minutes (0, 30, 60, 120, 180, and 240 minutes post meal challenge).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.