Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
NCT ID: NCT06155708
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-01-20
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Ketone
\- 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.
Ketone
\- 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.
Placebo
100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia
Water
100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia
Interventions
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Ketone
\- 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.
Water
100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia
Eligibility Criteria
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Inclusion Criteria
* All participants will be aged 18 to 40
* PCOS diagnosis
Exclusion Criteria
* Presence or history of overt cardiometabolic disease (e.g., stage 2 hypertension, diabetes, heart disease), neurologic disease, or endocrinopathy (with the exception of PCOS)
* Current pregnancy or currently breastfeeding
* Current use of medications which may affect our outcomes of interest (e.g., anti-hypertensives, anti-androgens, metformin)
18 Years
40 Years
ALL
Yes
Sponsors
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McGill University
OTHER
Responsible Party
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Charlotte Usselman
Primary Investigator
Principal Investigators
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Charlotte Usselman, Ph.D
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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Cardiovascular Health and Autonomic Research Laboratory
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-9710
Identifier Type: -
Identifier Source: org_study_id
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