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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 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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor

395 Previous Clinical Trials

999,317 Total Patients Enrolled

Charlotte Usselman, Ph.DPrincipal InvestigatorMcGill University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being accepted into the patient pool?

"Patients that meet the age criteria of being 18 years or older, but not yet 40 are eligible to partake in this trial."

Answered by AI

Am I eligible to participate in this scientific experiment?

"Recruiting 60 individuals, this trial requires that participants have been diagnosed with polycystic ovarian syndrome and are between 18 to 40 years of age."

Answered by AI

What overarching goals has this research set out to achieve?

"The principal outcome that will be monitored for a period of up to 2.5 hours post-ingestion is Flow mediated dilation (FMD). Other metrics such as Neurovascular transduction, Triglycerides area under the curve during oral glucose tolerance test, and Capillary blood Beta-OHB concentrations in mmol/L are also analysed by the research team."

Answered by AI

Is this research protocol still accepting participants?

"This particular medical study, first posted on January 1st 2024 and last updated December 1st 2023, is not accepting patients. However, there are 110 other trials that currently have an open enrollment status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exogenous Ketone Supplementation in Females With Polycystic Ovary Syndrome

Charlotte Usselman 2024. "Exogenous Ketone Supplementation in Females With Polycystic Ovary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06155708.

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