Ketone Monoester and Blood Pressure

Summary

The goal of this clinical trial is to determine the effect of acute consumption of a ketone monoester supplement in healthy male adults.

The main questions it aims to answer are:

* To determine if acute consumption of a ketone monoester supplement modulates diurnal (measured in lab) and nocturnal blood pressure (assessed by ambulatory blood pressure monitoring; ABPM) compared to a taste-matched placebo. The investigators hypothesize that a ketone monoester supplement will acutely decrease systolic and diastolic blood pressure compared to the placebo. The same results are expected for diurnal and nocturnal blood pressure.
* To determine if acute consumption of a ketone monoester supplement improves glucose control measured with continuous glucose monitoring (CGM) following a standardized meal consumed 90 minutes after ingestion of the ketone supplement. The investigators hypothesize that a ketone monoester supplement, consumed 90 minutes before a meal, will decrease the 2-hour postprandial glucose incremental area under the curve (iAUC) and peak glucose compared to a placebo.
* To assess IL-10's ability to inhibit proinflammatory cytokine production (TNF- α and IL-1β) in LPS-stimulated whole blood cultures following the ingestion of β-OHB and placebo. The investigators hypothesize that β-OHB will augment the ability of IL-10 to inhibit TNF-α and IL-1β production compared to placebo.

Using a double-blind placebo-controlled randomized crossover study design, 15 adults will participate in two experimental conditions. Participants will be recruited using a local recruitment database (Nabû), during presentations in community organizations, with posters at the University of Sherbrooke, and from word of mouth.

Following screening, eligible participants will be invited for one baseline and two experimental conditions at the Research Centre on Aging (CdRV). During the baseline visit, the following assessments and tests will be conducted:

* resting heart rate (HR) and blood pressure;
* anthropometry and body composition;
* medical history and questionnaires on physical activity levels, dietary habits and anxiety symptoms;
* explanation of the dietary and physical activity logs;
* installation of accelerometers to control physical activity levels and sedentary behaviors over 10 days and CGM to assess glucose control over the subsequent 10 consecutive days.

During the week following the baseline condition, participants will be invited to the laboratory for their first experimental condition (duration = 240 minutes). Participants will come to the lab in a fasted state (at least 12-hour overnight) to the lab at 8:00 am where following assessments and tests will be conducted:

* resting heart rate (HR) and blood pressure;
* ketone supplement or placebo consumption;
* blood samples and cold pressor test;
* standardized breakfast;
* galvanic skin response;
* visual analog scales assessing gastrointestinal discomfort, hunger and fullness;
* installation of ABPM and explanation of the dietary and physical activity logs.

Forty-eight hours later, participants will complete the same experimental condition with the alternate supplement (ketone or placebo) according to their randomization.

Conditions

• Blood Pressure

Interventions

DIETARY_SUPPLEMENT

BHB supplement

Oral consumption of 0.5 g/kg of a BHB supplement (KE4; Ketoneaid®, Falls Church, Virginia, USA)

OTHER

Placebo solution

80 to 120 ml of a placebo solution, depending on the participant's body weight, with the addition of stevia and bitter agent solution (Bitrex, Scotland, UK) as well as the same flavouring as the ketone supplement drink (provided by Ketoneaid)

Sponsors & Collaborators

• University of British Columbia

  collaborator OTHER

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Eléonor Riesco, PhD · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-30

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Canada

Study Locations