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Ketone Supplementation for Polycystic Ovary Syndrome

N/A

Waitlist Available

Led By Charlotte Usselman, Ph.D

Research Sponsored by McGill University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All participants will be aged 18 to 40

Be between 18 and 65 years old

Must not have

Current smokers or a prolonged history of smoking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Summary

This trial will investigate if ketone supplements can improve cardiovascular health in women with PCOS, a common disorder that can lead to CVD. #PCOS #Ketones #CVD #CardiovascularHealth

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for exogenous ketone supplements in this context, potential general side effects may include gastrointestinal discomfort such as nausea or stomach pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently smoking or have a long history of smoking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diastolic Blood Pressure (DBP)

Flow mediated dilation (FMD)

Glycemic responses to a 2-hr oral glucose tolerance test

+1 more

Secondary study objectives

Arterial artery blood flow

C-peptide

Capillary blood Beta-OHB concentrations

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: KetoneExperimental Treatment1 Intervention

- Ketone monoester supplement in the form of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.45ml/kg body weight) ingested with water and vanilla-flavored stevia in a total volume of 100 ml.

Group II: PlaceboPlacebo Group1 Intervention

100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketone

2020

N/A

~50

0 / 2Eligibility criteria met