RecruitingNAINTERVENTIONAL

Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome

This study is investigating a new approach for women with Polycystic Ovary Syndrome (PCOS). PCOS can affect many women and might increase their risk of heart problems later in life, partly due to issues like insulin resistance and high blood pressure. While often thought of as only affecting fertility, heart health is also a big concern for women with PCOS. Researchers are exploring if a special drink containing a ketone supplement can help. Ketones are substances usually made by the body and some studies suggest supplements could improve insulin and blood pressure in healthy people. This study will compare the ketone drink with a plain drink (placebo) to see if it improves how blood sugar is managed, how blood vessels work, blood pressure, and the body's response to exercise in women with PCOS. The aim is to find out if this could be a practical way to support heart health.

At a glance

Status

Recruiting

Phase

Sponsor

McGill University

Enrolment target

Start

20 Jan 2025

Estimated completion

01 Dec 2027

PCOS

What is this study about?

Polycystic Ovary Syndrome (PCOS) is a common condition affecting many women of childbearing age, about 1 in 5. While it's often talked about due to its impact on fertility, PCOS can also increase the risk of heart problems. This is because women with PCOS often experience issues like insulin resistance (where the body's cells don't respond well to insulin), problems with how blood vessels work, and higher blood pressure. These factors are important for keeping your heart healthy, and unfortunately, there aren't many treatments specifically designed to improve heart health for women with PCOS.

This research is looking at a new idea: using a special ketone supplement. Ketones are chemicals your body produces, especially when you're using fat for energy. Some early studies have suggested that taking ketone supplements might help improve things like insulin sensitivity, blood vessel function, and blood pressure in people who don't have PCOS, or who are at risk of heart problems. Researchers believe that if this is true, a simple oral ketone supplement could be a practical and effective way to help women with PCOS improve their heart health.

To find out, this study will ask participants to visit twice. On different days, they'll either drink a beverage with the ketone supplement or a plain drink without the active ingredient (a placebo). The researchers will then carefully measure various aspects of their health. This includes how their body handles sugar after a special drink, how well their blood vessels expand and contract, their blood pressure (both at rest and during light exercise), and how their body reacts to exercise. By comparing the effects of the ketone drink to the plain drink, and also looking at women without PCOS, the study hopes to understand if this supplement really can make a difference for heart health in women with PCOS.

Key takeaways

PCOS affects many women and can increase heart health risks.
This study explores a ketone supplement to improve heart health in PCOS.
Measurements include blood sugar, blood pressure, and blood vessel function.
Participants will drink either a ketone supplement or a plain placebo drink.
The goal is to find new, practical ways to support women with PCOS.

Who may be eligible?

To be part of this study, you need to be a woman who was assigned female at birth and is between 18 and 40 years old. You must also have a diagnosis of Polycystic Ovary Syndrome (PCOS).

There are some reasons you wouldn't be able to join. For example, if you currently smoke or have smoked for a long time, you wouldn't be eligible. Also, if you have a serious heart condition, diabetes, a nerve problem, or another hormone-related health issue (apart from your PCOS), this study might not be right for you.

Additionally, if you are currently pregnant or breastfeeding, or if you are taking certain medications that could affect the study's results (like treatments for high blood pressure, some hormone medicines, or metformin), you would not be able to participate. This helps make sure the study results are clear and accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman, assigned female at birth?
Are you between 18 and 40 years old?
Do you have a diagnosis of Polycystic Ovary Syndrome (PCOS)?
Are you a non-smoker, and have you not smoked for a long time?
Are you currently not pregnant or breastfeeding?
Are you not taking medications for high blood pressure, certain hormone medications, or metformin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study centre on two separate days. On each day, you'll drink either the ketone supplement beverage or a plain placebo beverage. The researchers will then perform several assessments. These include a test to see how your body handles sugar, a test to check how your blood vessels are working, measurements of your blood pressure, and monitoring how your body responds to some light exercise. The total time for these two visits will be explained by the study team. You'll likely be asked to follow certain instructions before each visit, such as not eating for a certain period.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as a better understanding of your own health and contributing to medical knowledge that might help other women with PCOS in the future. However, there might also be potential risks, such as mild side effects from the supplement or discomfort during some of the tests. All procedures will be explained in detail, and your safety is a priority. Remember, participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Cardiovascular Health and Autonomic Research Laboratory
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a ketone supplement?

A ketone supplement is a drink that contains ketones, which are substances usually made by your body when it uses fat for energy. This study is looking at whether taking them as a supplement can help with certain health markers.

What is 'insulin resistance'?

Insulin resistance means your body's cells don't respond as well to insulin, a hormone that helps control blood sugar. This can lead to higher blood sugar levels.

What does 'endothelial function' mean?

Endothelial function refers to how well the inner lining of your blood vessels (called the endothelium) works. Healthy endothelium is important for blood pressure control and overall heart health.

Will I know if I'm getting the ketone supplement or the plain drink?

No, this is a 'blinded' study. You won't know if you're getting the ketone supplement or the placebo (plain drink) to ensure the results are unbiased. The researchers won't know either until the end of the study.

When will the results of this study be available?

Clinical trials take time to complete and analyse the data. Once the study is finished and the results are peer-reviewed and published, they will likely be shared with the medical community and public. The study team can give you more details about their expected timeline.

How to find out more

Charlotte Usselman, Ph.D

charlotte.usselman@mcgill.ca 5143962140 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.