Higher Protein Diet for PCOS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas, Fayetteville

Must not be taking: Metformin, GLP-1 agonists, others

Disqualifiers: Smoking, Diabetes, Underweight, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a higher protein diet might help women with polycystic ovary syndrome (PCOS) improve heart and metabolic health. PCOS can lead to issues like type 2 diabetes and heart disease, particularly in those who are overweight. The study compares different diet plans to determine if increased protein intake can make a difference. Women with PCOS who have maintained a stable weight (within 5 pounds over the last 3 months) and are willing to consume both plant and animal proteins may be suitable candidates for this trial.

As an unphased study, this trial provides a unique opportunity to contribute to understanding dietary impacts on PCOS.

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications that could interfere with the study outcomes, such as metformin and GLP-1 agonists.

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

Studies have shown that a high-protein diet can help women with PCOS by improving insulin utilization. Insulin resistance, where the body doesn't use insulin effectively, can lead to health issues like type 2 diabetes. Research suggests that this diet may help manage these problems.

Although there was no significant drop in LDL cholesterol (often called "bad" cholesterol), some studies found that the diet did not negatively affect cholesterol levels. Additionally, increasing protein intake might help lower certain hormones that are often elevated in women with PCOS, which could be beneficial.

Overall, these findings suggest that a high-protein diet is generally well-tolerated by women with PCOS and may offer health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the higher protein dietary pattern for PCOS because it offers a fresh approach compared to the standard treatments, which typically involve hormonal therapy and insulin-sensitizing medications. Unlike these traditional methods, this dietary approach focuses on increasing protein intake to potentially balance hormones and manage insulin levels naturally. This method is non-invasive and could lead to fewer side effects, making it an appealing option for those seeking lifestyle-based management of PCOS. Additionally, by adjusting diet, it empowers individuals to take an active role in managing their condition in a sustainable way.

What evidence suggests that this trial's treatments could be effective for PCOS?

This trial will compare a higher protein dietary pattern with calorie restriction for women with PCOS. Research has suggested that increasing protein intake might improve insulin response in women with PCOS, which is crucial for blood sugar control. One study found that a high-protein diet resulted in greater weight and body fat loss compared to regular diets. However, the effects on cholesterol levels remain unclear, with no major changes observed in some types of cholesterol. Overall, increasing protein intake could enhance heart and metabolic health in women with PCOS, but further research is needed for confirmation. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women of reproductive age who have Polycystic Ovary Syndrome (PCOS). It's aimed at those interested in exploring dietary changes to improve their health, specifically through higher protein intake and calorie restriction.

Inclusion Criteria

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

Consumption of more than 0.8 g/protein/kg body weight

Taking nutritional supplements

Underweight

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a higher protein diet intervention to assess its effects on cardiometabolic health in women with PCOS

16 weeks

Visits every 4 weeks for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calorie restriction
• Higher protein dietary pattern

Trial Overview The study tests the effects of a high-protein diet on cardiometabolic health in women with PCOS. Participants will follow a diet where 30% of total energy comes from protein, aiming to see if this improves body composition and metabolic markers.

How Is the Trial Designed?

Group I: Control and Protein Active Control 1 Intervention

Group II: Calorie restricted control Active Control 1 Intervention

Group III: Calorie restricted PCOS Active Control 1 Intervention

Group IV: PCOS Protein Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Arkansas, Fayetteville

Lead Sponsor

Trials

24

Recruited

2,100+

Arkansas Biosciences Institute

Collaborator

Trials

2

Recruited

330+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10904368/

Effects of high-protein diets on the cardiometabolic factors and ... HPDs may benefit women with PCOS in terms of improving insulin resistance, supporting for their use as one of the dietary management options for PCOS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07158723

Protein and Polycystic Ovary Syndrome (PCOS) However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523026254

Effects of increased dietary protein-to-carbohydrate ratios ... The HP diet produced a greater weight loss (mean: 4.4 kg; 95% CI: 0.3, 8.6 kg) and body fat loss (mean: 4.3 kg; 95% CI: 0.9, 7.6 kg) than the SP diet after 6 mo ...

4. mdpi.com mdpi.com/2072-6643/17/4/674

The Influence of Dietary Patterns on Polycystic Ovary ... A significant decrease in TC was found in one [52] of three RCTs [13,14,52]. The high-protein diet showed no significant decrease in LDL-C in two RCTs [13,14].

5. reproductive-health-journal.biomedcentral.com reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-024-01758-5

Ranking the dietary interventions by their effectiveness in the ... Dietary interventions vary in their effects on metabolic parameters in women with PCOS. Based on our results, the DASH diet is the most effective dietary ...

6. bmcendocrdisord.biomedcentral.com bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-022-01208-y

Lifestyle management in polycystic ovary syndrome – beyond ... In women with PCOS higher protein intakes may be superior at supressing androgen levels when compared to high carbohydrate diets. Postprandial ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027153172200001X

Higher dietary inflammation potential and certain ... A pro-inflammatory diet had higher odds of polycystic ovary syndrome (PCOS). The Mediterranean diet reduced the risk of PCOS, while the meat-egg and ...