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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 40 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diastolic Blood Pressure (DBP)
Flow mediated dilation (FMD)
Glycemic responses to a 2-hr oral glucose tolerance test
+1 more
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor
398 Previous Clinical Trials
1,000,220 Total Patients Enrolled
Charlotte Usselman, Ph.DPrincipal InvestigatorMcGill University
~40 spots leftby Jun 2027
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