Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06155708
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-10-18
Brief Title:
Exogenous Ketone Supplementation in Females With Polycystic Ovary Syndrome
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females With Polycystic Ovary Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None