Clinical Trials Directory

Trials / Completed

CompletedNCT06683547

The Impact of Ketone Monoester Intake on Post-exercise Hormonal Responses After Resistance Exercise in Young Males

The Impact of Ketone Monoester Intake on Post-exercise Hormonal Response During Recovery Following an Acute Bout of Resistance Exercise.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
McGill University · Academic / Other
Sex
Male
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

This study investigates how orally ingested exogenous ketone monoester supplements affect circulating hormone concentrations in healthy young adult males after a single session of resistance exercise. Resistance exercise is known to stimulate an acute increase in the circulating concentration of various hormones that are involved in the regulation of muscle mass, including testosterone, growth hormone (GH), and insulin-like growth factor-1 (IGF-1). Recently, there has been growing interest in how nutritional supplements impact these natural hormone responses at rest. One such intervention is the oral ingestion of exogenous ketone body supplements. Ketone bodies (i.e., β-hydroxybutyrate (β-HB), acetoacetate (AcAc), and acetone) are naturally occurring compounds that are normally produced by the body during prolonged fasting/starvation, or in response to a "ketogenic" diet (a diet very high in fat and very low in carbohydrates). These ketone body supplements taken in the form of a ketone monoester can quickly raise blood ketone levels without needing to change your diet. Recent research has shown that the ingestion of exogenous ketone supplements or following a 'ketogenic diet' can alter the concentration of certain hormones measured in blood samples at rest. However, the effects of ketone monoester intake on the exercise-induced elevation in circulating hormones is yet to be explored. Therefore, the purpose of this study is to examine how elevated β-HB, induced via the ingestion of the ketone monoester (R)-3-hydroxybutyl-(R)-3-hydroxybutyrate, affects blood concentrations of various anabolic hormones, during post-exercise recovery in healthy young adult males, compared to a placebo drink (flavoured water).

Detailed description

A within-subject crossover design will be used for this randomized, double-blind, placebo-controlled study in healthy males to investigate the impact of ketone monoester (KET) intake on circulating (blood) concentrations of 'anabolic' and other hormones. There are two treatment arms in this crossover trial, including one KET arm and one placebo group. A total of 12 participants will be enrolled and undergo both treatment phases with a minimum 7-day washout period between lab visits. The study will include a screening visit (Visit 1), 10-repetition maximum (10-RM) testing (visit 2), where participants' 10-RM will be determined for each exercise machine used, experimental trial (visit 3), minimum 7-day washout, followed by the phase 2 of the experimental trial (visit 4). During the experimental trials, participants will arrive to the laboratory in an overnight fasted state, and the KET or placebo drink will then be administered following basal blood collection. Then, participants will perform a lower-body resistance exercise session consisting of 5 sets of 10 repetitions of leg press and 3 sets of 12 repetitions of leg extension/leg curl supersets at 95% of their determined 10-RM. Following exercise, another dose of the nutritional treatment will be administered. Arterialized blood samples will then be collected at 13 postprandial timepoints during the 1-hour rested period and the 4-hour post-exercise recovery period to measure changes in plasma glucose and insulin concentration. Arterialized blood samples will also be utilized for quantitation of anabolic hormones, including testosterone, IGF-1, GH, cortisol, luteinizing hormone, sex-hormone binding globulin, dehydroepiandrosterone, estrogen, progesterone, and follicle-stimulating hormone. Additionally, changes in capillary blood β-HB concentration will be assessed throughout the trials by collecting capillary blood samples at baseline and 11 postprandial timepoints during the 1-hour rested period and the 4-hour post-exercise recovery period.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKetone Monoester (KET)Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight). The ketone brand name: delta G Oxford Ketone Ester.
DIETARY_SUPPLEMENTFlavour matched placebo drink (CON)\- Flavoured water (non-caloric bitter + citrus flavours)
OTHERResistance Exercise\- 5 sets of 10 repetitions of leg press and 3 sets of 12 repetitions of leg extension/leg curl 'supersets' (1 set of each back to back with no rest in between sets) at 95% of their 10-RM. Between-set rest intervals for the leg exercises will be 60 seconds.

Timeline

Start date
2025-01-06
Primary completion
2025-07-27
Completion
2025-07-27
First posted
2024-11-12
Last updated
2025-09-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT06683547. Inclusion in this directory is not an endorsement.