Protein Meals for Polycystic Ovary Syndrome

Overseen By Sydney Boudrey, MS, RDN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas, Fayetteville

Must not be taking: Metformin, GLP-1 agonists

Disqualifiers: Smoking, Marijuana, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how different protein sources affect women with polycystic ovary syndrome (PCOS), a condition that can disrupt insulin and hormone levels. Researchers will compare meals made from plant protein and animal protein to assess their effects on blood sugar and post-meal fullness. Women with PCOS, who have maintained a stable weight recently and are open to trying both types of meals, may be suitable candidates for this study. This research could inform better diet plans for managing PCOS symptoms. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to improved dietary recommendations for managing PCOS.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interfere with the study, like metformin or GLP-1 agonists. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that meals high in animal protein can affect insulin and sugar levels in people with PCOS. Some studies suggest that consuming large amounts of red and processed meats might increase the risk of developing PCOS.

In contrast, plant proteins often provide benefits like more fiber and essential nutrients. However, the specific effects of plant proteins on women with PCOS have not been as thoroughly studied.

Overall, both types of protein are generally considered safe to consume. It is important to consider personal dietary needs and potential risks. Consulting a healthcare provider before changing one's diet is advisable, especially for those with PCOS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing plant and animal protein meals for managing Polycystic Ovary Syndrome (PCOS) because these dietary interventions offer a nutritional approach that differs from conventional treatments like hormonal therapy and insulin-sensitizing drugs. Unlike these standard treatments, which often focus on medication, this trial investigates how the body's appetite and metabolism respond to different protein sources. By exploring plant and animal proteins, researchers aim to uncover dietary strategies that could help manage PCOS symptoms naturally, potentially leading to more personalized and non-pharmacological management options for patients.

What evidence suggests that this trial's protein meals could be effective for managing PCOS?

Research has shown that meals high in protein can help control insulin and sugar levels in women with polycystic ovary syndrome (PCOS). High-protein meals lower insulin levels, which is crucial because many women with PCOS struggle with insulin regulation. In this trial, participants will be assigned to different treatment arms to evaluate the effects of protein sources. One arm will focus on animal proteins, like meat and eggs, which might be particularly beneficial due to their important nutrients that can influence insulin. Another arm will examine plant proteins, like beans and nuts, which offer benefits such as fiber that helps maintain steady blood sugar levels. This trial will assess how these different protein sources affect insulin and sugar levels in women with PCOS. Understanding these effects could lead to improved dietary advice for managing PCOS. ^{1 2 4 6 7}

Who Is on the Research Team?

Jamie I Baum, PhD

Principal Investigator

University of Arkansas, Fayetteville

Are You a Good Fit for This Trial?

This trial is for women with Polycystic Ovary Syndrome (PCOS), which often involves insulin resistance and hormonal imbalances. The study aims to understand how different protein sources in meals affect their metabolism and hormone levels.

Inclusion Criteria

Stable body weight for at least 3 months (+ 5 pounds)

I am a woman aged between 18 and 50.

Body mass index (BMI) between 18.5 and 35 kg/m2

Exclusion Criteria

Smoking or use of nicotine products

Smoking or use of marijuana products

Food allergies or dietary restrictions incompatible with test meals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Meal Challenge

Participants undergo meal challenges with plant and animal protein to assess postprandial responses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after meal challenges

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Protein Source Comparison

Trial Overview The study is testing the body's metabolic response to different types of proteins—specifically comparing plant-based proteins versus animal-based proteins—in women with PCOS, to see which might better manage blood sugar and appetite hormones after eating.

How Is the Trial Designed?

Group I: Animal Protein Challenge Experimental Treatment 1 Intervention

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.

Group II: Plant protein challenge Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07142603

Appetite Response to Meals With Different Protein Sources ... This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform ...

2. withpower.com withpower.com/trial/phase-polycystic-ovary-syndrome-7-2025-14956

Protein Meals for Polycystic Ovary Syndrome This study will assess whether plant and animal protein meals elicit differential postprandial responses in women with PCOS. Findings may inform dietary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9841505/

Lifestyle management in polycystic ovary syndrome Postprandial research has shown that high protein meals can reduce insulin and dehydroepidiandrosteone stimulation compared to meals rich in ...

4. nature.com nature.com/articles/s41598-024-80238-z

The association between dietary obesity-prevention score ... For example, higher dietary n-3 PUFA intake was associated with a lower prevalence of PCOS and reduced WC and BMI among PCOS patients. In ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666396125000147

The last update on polycystic ovary syndrome(PCOS) ... Research shows that adopting the MedDiet decreases oxidative stress (OS) and inflammation, and improves insulin sensitivity, lipid profiles, and endothelial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007253/

The association between meat consumption and polycystic ... Higher consumption of red meat increased the risk of PCOS by 3.87 times. Furthermore, higher consumption of processed meats increased the risk ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/rmb2.12607

The impact of dietary interventions on polycystic ovary ... Dietary interventions can improve the clinical manifestations of PCOS and pregnancy rates in patients with a BMI ≥ 25 kg/m 2.