Oral Contraceptives + Resistant Starch for Polycystic Ovary Syndrome

(COR-PCOS Trial)

Overseen By Andrea Morley

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Must be taking: Oral contraceptives

Must not be taking: Lipid lowering, Probiotics, Laxatives, Antibiotics

Disqualifiers: Diabetes, Liver disease, Renal disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding resistant starch to oral contraceptive treatment can improve heart, metabolism, or gut health in women with polycystic ovary syndrome (PCOS). Participants will receive either resistant starch, a type of dietary fiber, or a placebo, and researchers will compare the effects. Women who may be suitable for this trial include those with PCOS who have fewer than eight periods a year or excess male hormones and are willing to avoid pregnancy during the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications for this trial?

The trial requires that participants do not take medications that affect weight or metabolic parameters, such as lipid-lowering medications. If you are on such medications, you may need to stop them to participate.

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

Research has shown that resistant starch, often used as a prebiotic, is generally safe to consume and is recognized as safe in foods. Studies suggest it may aid in metabolism and hormone regulation, though results vary and not all studies agree on its benefits.

Oral contraceptives, commonly prescribed for conditions like PCOS, have been extensively researched. They are widely used and typically well-tolerated. Some individuals might experience side effects such as nausea or headaches, but many use them without issues.

Overall, both resistant starch and oral contraceptives have been studied for safety and are generally considered safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for PCOS?

Researchers are excited about using resistant starch alongside oral contraceptives for polycystic ovary syndrome (PCOS) because it offers a new way to manage the condition. Unlike standard treatments that mainly focus on regulating hormones, resistant starch, like wheat dextrin, may improve insulin sensitivity and reduce inflammation, both of which are common issues in PCOS. This dietary fiber could complement existing therapies by addressing some of the metabolic aspects of PCOS, potentially offering a more comprehensive approach to treatment.

What evidence suggests that resistant starch could be an effective treatment for PCOS?

Research has shown that resistant dextrin, a type of resistant starch, can improve certain health markers in people with polycystic ovary syndrome (PCOS). Studies have found that it helps control insulin levels and alleviates symptoms like excessive hair growth and irregular periods. Additionally, it supports the growth of beneficial gut bacteria, which is crucial for overall gut health. These effects suggest that resistant starch might manage PCOS by addressing metabolic issues and gut bacteria imbalances. This trial examines resistant starch as a potential treatment option for PCOS, alongside other treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for women with Polycystic Ovary Syndrome (PCOS) who are interested in exploring the effects of oral contraceptive pills combined with resistant starch. Participants should not have other significant health issues that could interfere with the study.

Inclusion Criteria

I have PCOS with high male hormone levels only.

Subjects willing to avoid pregnancy for the entire duration of the study

I may have irregular periods due to low progesterone.

Exclusion Criteria

My irregular periods are not due to pregnancy, breastfeeding, thyroid issues, high prolactin levels, or early menopause.

Subjects unable to comply with the study procedures due to mental illness, substance abuse, or participation in other studies

Subjects with greater than 20 g/day of dietary fiber intake

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral contraceptive pills followed by either 12 weeks of resistant starch or 12 weeks of placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral Contraceptives
• Resistant Starch

Trial Overview

The study tests if adding resistant starch to standard low-dose oral contraceptives can improve heart health and gut balance in women with PCOS. It compares 12 weeks on resistant starch versus a placebo, alongside contraceptive use.

How Is the Trial Designed?

Group I: Resistant Starch Active Control 2 Interventions

wheat dextrin

Group II: Placebo Placebo Group 2 Interventions

maltodextrin

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a systematic review of 14 randomized controlled trials involving 707 nonobese women with PCOS, the combination of oral contraceptives (OCs) and metformin significantly improved fasting glucose and insulin levels compared to OCs alone.

While the combination treatment enhanced glucose metabolism, it did not show significant differences in other metabolic markers like cholesterol or insulin resistance, suggesting that metformin specifically benefits glucose regulation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral contraceptives (OCs) in combination with metformin versus OCs alone on metabolism in nonobese polycystic ovary syndrome: A meta-analysis and systematic review of randomized controlled trials. Wu, L., Liu, Y., Huang, X., et al.[2023]

In a study of 60 women with PCOS, the combination of the contraceptive pill Diane35 and metformin was more effective in reducing hyperandrogenemia and insulin levels compared to metformin alone, suggesting a synergistic effect in managing PCOS symptoms.

Diane35 restored menstrual regularity in all patients, while metformin significantly reduced body mass index and waist-to-hip ratio in obese patients, highlighting the distinct benefits of each treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of metformin and ethinyl estradiol-cyproterone acetate on clinical, endocrine and metabolic factors in women with polycystic ovary syndrome. Wu, J., Zhu, Y., Jiang, Y., et al.[2013]

In a study of 119 women with polycystic ovary syndrome (PCOS), persistence rates for oral contraceptive pills (OCPs) and metformin were similar at 3 months (57.1% for OCPs vs. 57.8% for metformin), indicating both treatments are equally accepted initially.

However, persistence with both treatments significantly declined over time, with only 21.7% continuing OCPs and 31.2% continuing metformin at 12 months, highlighting a challenge in long-term adherence to treatment for PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistence with oral contraceptive pills versus metformin in women with polycystic ovary syndrome. Karjane, NW., Cheang, KI., Mandolesi, GA., et al.[2022]

Targeting insulin resistance in women with PCOS can lead to significant improvements in hormonal balance, metabolism, and ovulation, which may enhance fertility.

The treatment approach for PCOS should be personalized based on individual factors such as age, degree of androgen excess, presence of obesity, and fertility desires, with options including lifestyle changes, insulin sensitizers like metformin, and hormonal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting insulin sensitivity in the treatment of polycystic ovary syndrome. Pasquali, R., Gambineri, A.[2013]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29480399/

The effect of resistant dextrin as a prebiotic on metabolic ...

Conclusion: Resistant dextrin consumption can regulate metabolic parameters and androgen levels and manifestations including hirsutism and menstrual cycle ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8621223/

Efficiency of Resistant Starch and Dextrins as Prebiotics

Ingestion of resistant dextrin also promoted the growth of important gastrointestinal microbiota, involved in the production of SCFA, e.g., ...

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prebioticassociation.org

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Prebiotic Type Spotlight: Resistant Dextrin

Supplementation of RD in overweight men led to significant improvements in determinants of metabolic syndrome, lowered insulin resistance, and was found to be ...

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Gut microbiota: a hidden player in polycystic ovary syndrome

According to a study findings, frequent consumption of resistant dextrin, a prebiotic, might aid in the control of metabolic parameters and ...

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The effect of resistant dextrin as a prebiotic on metabolic ...

According to a study findings, frequent consumption of resistant dextrin, a prebiotic, might aid in the control of metabolic parameters and ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S175646462500338X

The effect of pre/pro/synbiotics on cardiometabolic health ...

Although many studies have revealed the benefits of biotics on health outcomes in women with polycystic ovary syndrome (PCOS), the findings are inconclusive.

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tandfonline.com

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Resistant Dextrin Preexistence and Fate: Preparation ...

It has been approved as a Generally Recognized as Safe food which has a promising future. However, there is less comprehensive basic and applied ...