PCOSNCT06155708
Exogenous Ketone Supplementation in Females with Polycystic Ovary Syndrome
A study testing Ketone and Water in people with PCOS, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- Ketone and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All female participants will report female sex assigned at birth
- All participants will be aged 18 to 40
- PCOS diagnosis
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cardiovascular Health and Autonomic Research Laboratory
Montreal, Quebec, H2W 1S4
Charlotte Usselman, Ph.D, charlotte.usselman@mcgill.ca
About this study
Official title: Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome
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.
Read more
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.
- Conditions
- PCOS
- Being tested
- Ketone, Water
- Keywords
- Polycystic ovary syndrome, Ketone monoester ingestion, Insulin resistance, Endothelial function, Blood pressure, Oral glucose tolerance test, Flow mediated dilation, Handgrip exercise, Neurovascular transduction, Cold pressor test
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoneDietary 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.
WaterDietary supplement
100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia
| Study group | Role | What they receive |
|---|---|---|
| Ketone | Experimental | - 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. Receives: Dietary Supplement: Ketone |
| Placebo | Placebo comparator | 100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic responses to a 2-hr oral glucose tolerance test
- Glucose is calculated by the area under the curve using the trapezoid method.
Measured: 0-2.5 hours in the post-prandial period
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.
Measured: 30 minutes
Systolic Blood Pressure (SBP)
- SBP, measured in mmHg
Measured: 2 hours
Diastolic Blood Pressure (DBP)
- DBP, measured in mmHg
Measured: 2 hours
Secondary outcomes (16)
Insulin area under the curve
- Insulin area under the curve during oral glucose tolerance test
Measured: 0-2.5 hours in the post-prandial period
C-peptide
- C-peptide area under the curve during oral glucose tolerance test
Measured: 0-2.5 hours in the post-prandial period
Glucagon-like peptide-1 (GLP-1)
- GLP-1 area under the curve during oral glucose tolerance test.
Measured: 0-2.5 hours in the post-prandial period
Glucose-dependent insulinotropic polypeptide (GIP)
- GIP area under the curve during oral glucose tolerance test.
Measured: 0-2.5 hours in the post-prandial period
Triglycerides
- Triglycerides area under the curve during oral glucose tolerance test
Measured: 0-2.5 hours in the post-prandial period
Insulinogenic index
- (Insulin at 30 min - fasting insulin)/ (plasma glucose at 30 min- fasting plasma glucose).
Measured: 0-2.5 hours in the post-prandial period
Arterial artery blood flow
- Calculated as the product of mean blood flow velocity (cm/sec) and cross-sectional area (2Πr2) x 60 sec/min.
Measured: 0-2.5 hours in the post-prandial period
Shear rate and low-flow mediated vasoconstriction to the FMD
- Shear rate calculated as area under the curve from cuff deflation to the time of peak dilation using the trapezoidal rule, as well as low flow-mediated vasoconstriction during forearm occlusion, which provides an index of the endothelial contribution to resting vascular tone and which predicts cardiovascular disease risk.
Measured: 30 minutes
Muscle sympathetic nerve activity (MSNA)
- Measured using microneurography, and expressed in burst/min or bursts/100 heart beats
Measured: 2 hours
Neurovascular transduction
- Assessed by the MSNA signal (recorded in both raw and filtered/rectified/integrated formats for subsequent analyses) and arterial blood flow extracted on a beat-by-beat basis and processed using custom transduction software.
Measured: 2 hours
Vascular resistance
- Calculated as mean arterial pressure divided by Finometer-derived cardiac output
Measured: 2 hours
Capillary blood Beta-OHB concentrations
- Measures in mmol/L
Measured: 0-2.5 hours in the post-prandial period
Serum testosterone
- Measured in pg/ml.
Measured: 5 minutes
Serum sex hormone binding globulin
- Measured in pg/ml.
Measured: 5 minutes
Serum estradiol
- Measured in pg/ml.
Measured: 5 minutes
Serum Progesterone
- Measured in pg/ml.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start20 Jan 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Usselman, McGill University
- Investigators
- Charlotte Usselman, Ph.D, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155708
- Sponsor's protocol ID
- 2024-9710
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Ketone Supplementation to Improve Cardiovascular Disease Risk Factors in Females with Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06155708
- Acronym / sponsor ID
- 2024-9710
- Conditions
- PCOS
- Keywords
- Polycystic ovary syndrome, Ketone monoester ingestion, Insulin resistance, Endothelial function, Blood pressure, Oral glucose tolerance test, Flow mediated dilation, Handgrip exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone | Experimental | 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. |
| Placebo | Placebo comparator | Dietary Supplement: Water100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All female participants will report female sex assigned at birth
- All participants will be aged 18 to 40
- PCOS diagnosis
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Ketone |
| Water100 ml water combined with 10ml bitter flavor and vanilla-flavored stevia | Dietary supplement | Placebo |
Primary outcome
Glycemic responses to a 2-hr oral glucose tolerance test
Time frame: 0-2.5 hours in the post-prandial period
- Glucose is calculated by the area under the curve using the trapezoid method.
Flow mediated dilation (FMD)
Time frame: 30 minutes
- 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.
Systolic Blood Pressure (SBP)
Time frame: 2 hours
- SBP, measured in mmHg
Diastolic Blood Pressure (DBP)
Time frame: 2 hours
- DBP, measured in mmHg
16 secondary outcomes
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
Serum testosterone
Time frame: 5 minutes
Serum sex hormone binding globulin
Time frame: 5 minutes
Serum estradiol
Time frame: 5 minutes
Serum Progesterone
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Usselman, Ph.D principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone and Water in people with PCOS, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Usselman, Ph.D (5143962140, charlotte.usselman@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic responses to a 2-hr oral glucose tolerance test (time frame: 0-2.5 hours in the post-prandial period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.