60 Participants Needed

Ketone Supplementation for Polycystic Ovary Syndrome

CU
Overseen ByCharlotte Usselman, Ph.D

What You Need to Know Before You Apply

What is the purpose of this trial?

Polycystic ovary syndrome (PCOS) affects 1 in 5 females of reproductive age. Commonly characterized as a disorder of infertility, PCOS is often accompanied by 3 potent cardiovascular disease (CVD) risk factors: insulin resistance, endothelial dysfunction, and elevated blood pressure. Accordingly, PCOS is associated with the development of CVD, the second leading cause of death in females in Canada. However, effective treatments to improve cardiovascular health in PCOS are lacking.Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure regulation in healthy individuals and individuals predisposed to CVD. Therefore, oral ketone supplements offer a practical and effective strategy for improving cardiovascular health; however, this treatment has yet to be evaluated in PCOS.Therefore, the overall goal of this project is to employ KME ingestion to improve markers of cardiovascular health in females with PCOS.On two different days, participants will consume either a beverage containing a ketone supplement or a beverage containing a placebo supplement. The objectives are to compare responses between KME and placebo ingestion, and examine all outcomes related to cardiovascular health in females with PCOS in comparison with female controls of similar age and body mass index. The effects of KME ingestion will be quantified on: 1) glycemic control during an oral glucose tolerance test; 2) endothelial function using the flow-mediated dilation test; 3) blood pressure and acute blood pressure regulation; and 4) hemodynamic responses to acute exercise.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that could affect the study's outcomes, such as blood pressure medications, anti-androgens, and metformin.

How does exogenous ketone supplementation differ from other treatments for PCOS?

Exogenous ketone supplementation is unique because it provides an alternative energy source by increasing ketone levels in the body, which may help manage insulin resistance, a common issue in PCOS. Unlike other treatments that focus on hormone regulation or antioxidant effects, this approach targets metabolic pathways directly.12345

What data supports the effectiveness of the treatment Exogenous Ketone Supplementation for Polycystic Ovary Syndrome?

Research on ketogenic diets, which increase ketone levels in the body, shows benefits for women with PCOS, such as weight loss, improved insulin sensitivity, and better reproductive health. These findings suggest that ketone supplementation might also help manage PCOS symptoms.16789

Who Is on the Research Team?

CU

Charlotte Usselman, Ph.D

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for females aged 18 to 40 who have been diagnosed with Polycystic Ovary Syndrome (PCOS). Participants must not be current smokers or have a significant smoking history, and should not have any major heart, metabolic, neurological diseases, or other endocrine disorders besides PCOS. They also shouldn't be pregnant, breastfeeding, or on medications that could affect the study's outcomes.

Inclusion Criteria

I have been diagnosed with PCOS.
I was assigned female at birth.

Exclusion Criteria

I am currently smoking or have a long history of smoking.
I have or had serious heart, blood pressure, brain, hormone diseases except for PCOS.
Current pregnancy or currently breastfeeding
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either a ketone supplement or a placebo on two different days to assess cardiovascular health markers

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Exogenous Ketone Supplementation
Trial Overview The trial is testing whether drinking a ketone supplement can improve cardiovascular health in women with PCOS. It compares the effects of this supplement to a placebo drink on blood sugar control after eating glucose, blood vessel function, blood pressure regulation during rest and exercise.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials
421
Recruited
1,017,000+

Published Research Related to This Trial

A ketogenic diet (KD) significantly improved liver function markers in obese women with polycystic ovary syndrome (PCOS) and liver dysfunction, with six out of seven participants showing resolution of fatty liver after 12 weeks, compared to only one out of ten in the control group.
The KD group also experienced notable reductions in body weight and blood glucose levels, alongside improvements in menstrual cycle regularity, demonstrating its potential as an effective alternative to conventional pharmacological treatments.
Ketogenic diet in women with polycystic ovary syndrome and liver dysfunction who are obese: A randomized, open-label, parallel-group, controlled pilot trial.Li, J., Bai, WP., Jiang, B., et al.[2021]
The ketogenic diet (KD) significantly improved metabolic parameters in DHEA-induced PCOS mice, including reduced body weight and lower blood glucose levels, while also increasing blood ketone levels after 1 to 3 weeks of treatment.
KD treatment enhanced ovarian function and reduced inflammation and cell apoptosis in the ovaries of PCOS mice, suggesting that the ketone body β-hydroxybutyrate may play a key role in these therapeutic effects.
Effects of a ketogenic diet on reproductive and metabolic phenotypes in mice with polycystic ovary syndrome†.Liu, S., Yao, Q., Li, X., et al.[2023]
The ketogenic diet (KD) shows promise in managing polycystic ovary syndrome (PCOS) by improving insulin sensitivity, regulating weight, and enhancing metabolic health, particularly in adolescents with excessive body weight.
Despite its potential benefits, there is limited research specifically on the effects of a low-calorie ketogenic diet in adolescents with PCOS, highlighting the need for further studies to clarify its long-term impacts on fertility and metabolic health.
Low-Calorie Ketogenic Diet: Potential Application in the Treatment of Polycystic Ovary Syndrome in Adolescents.Calcaterra, V., Cena, H., Sottotetti, F., et al.[2023]

Citations

Ketogenic diet in women with polycystic ovary syndrome and liver dysfunction who are obese: A randomized, open-label, parallel-group, controlled pilot trial. [2021]
Effects of a ketogenic diet on reproductive and metabolic phenotypes in mice with polycystic ovary syndrome†. [2023]
Low-Calorie Ketogenic Diet: Potential Application in the Treatment of Polycystic Ovary Syndrome in Adolescents. [2023]
Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. [2022]
The Impact of Nutritional Therapy in the Management of Overweight/Obese PCOS Patient Candidates for IVF. [2023]
Antioxidant supplements relieve insulin resistance but do not improve lipid metabolism in women with polycystic ovary syndrome: a meta-analysis of randomized clinical trials. [2023]
The Effects of Vitamin D Supplementation on Metabolic Status of Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. [2018]
The Effects of Vitamin D-K-Calcium Co-Supplementation on Endocrine, Inflammation, and Oxidative Stress Biomarkers in Vitamin D-Deficient Women with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. [2017]
Natural Molecules in the Management of Polycystic Ovary Syndrome (PCOS): An Analytical Review. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security