Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketone, Water.
- Who it may be relevant to
- Registry conditions: PCOS. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome
Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement Water
100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia
Primary outcome measures
- Glycemic responses to a 2-hr oral glucose tolerance test [Time frame: 0-2.5 hours in the post-prandial period]
- Flow mediated dilation (FMD) [Time frame: 30 minutes]
- Systolic Blood Pressure (SBP) [Time frame: 2 hours]
- Diastolic Blood Pressure (DBP) [Time frame: 2 hours]
Secondary outcome measures (12)
- Insulin area under the curve [Time frame: 0-2.5 hours in the post-prandial period]
- C-peptide [Time frame: 0-2.5 hours in the post-prandial period]
- Glucagon-like peptide-1 (GLP-1) [Time frame: 0-2.5 hours in the post-prandial period]
- Glucose-dependent insulinotropic polypeptide (GIP) [Time frame: 0-2.5 hours in the post-prandial period]
- Triglycerides [Time frame: 0-2.5 hours in the post-prandial period]
- Insulinogenic index [Time frame: 0-2.5 hours in the post-prandial period]
- Arterial artery blood flow [Time frame: 0-2.5 hours in the post-prandial period]
- Shear rate and low-flow mediated vasoconstriction to the FMD [Time frame: 30 minutes]
- Muscle sympathetic nerve activity (MSNA) [Time frame: 2 hours]
- Neurovascular transduction [Time frame: 2 hours]
- Vascular resistance [Time frame: 2 hours]
- Capillary blood Beta-OHB concentrations [Time frame: 0-2.5 hours in the post-prandial period]
Eligibility criteria
Inclusion criteria
- All female participants will report female sex assigned at birth
- All participants will be aged 18 to 40
- PCOS diagnosis
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Cardiovascular Health and Autonomic Research Laboratory — Montreal
Identifiers
NCT: NCT06155708 · 2024-9710