Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
ConditionPCOS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorMcGill University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All female participants will report female sex assigned at birth
All participants will be aged 18 to 40
PCOS diagnosis
Disqualifiers
Current smokers or a prolonged history of smoking
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Ketone
Dietary supplement\- 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
Dietary supplement100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: KetoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Glycemic responses to a 2-hr oral glucose tolerance test
\- Glucose is calculated by the area under the curve using the trapezoid method.
Time frame
0-2.5 hours in the post-prandial period2
Flow mediated dilation (FMD)
\- Endothelial function is assessed using the standard FMD; quantified as the percent increase in diameter from rest to peak diameter observed during reactive hyperemia (%FMD). The % change in diameter reflects the ability of the vessel to dilate in response to sheer stress induced by the flow following the release of occlusion. This reflects the function of the endothelium, or release of nitric oxide.
Time frame
30 minutes3
Systolic Blood Pressure (SBP)
\- SBP, measured in mmHg
Time frame
2 hours4
Diastolic Blood Pressure (DBP)
\- DBP, measured in mmHg
Time frame
2 hoursSecondary outcomes
1
Insulin area under the curve
\- Insulin area under the curve during oral glucose tolerance test
Time frame
0-2.5 hours in the post-prandial period2
C-peptide
\- C-peptide area under the curve during oral glucose tolerance test
Time frame
0-2.5 hours in the post-prandial period3
Glucagon-like peptide-1 (GLP-1)
\- GLP-1 area under the curve during oral glucose tolerance test.
Time frame
0-2.5 hours in the post-prandial period4
Glucose-dependent insulinotropic polypeptide (GIP)
\- GIP area under the curve during oral glucose tolerance test.
Time frame
0-2.5 hours in the post-prandial periodSponsors and contacts
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Source ClinicalTrials.gov