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KetosisNCT06683547

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

A study testing Ketone Monoester (KET) and Resistance Exercise in people with Ketosis and Blood Hormones, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
Ketone Monoester (KET) and Resistance Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteCanada
Study dates
6 Jan 2025to 27 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult male participants who are 18-40 years of age (inclusive).
  • BMI >18.5 and <30.0 kg/m2
  • Recreationally active (at least of 150 minutes of activity/week).
  • Has maintained stable use of medication and supplements (which are not limited by the exclusion criteria), stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study.
  • Be willing to entirely avoid alcohol consumption 48 hours prior to the test days.
  • Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Who cannot join

  • Individuals with metabolic disorders including: Type I or Type II diabetes.
  • Individuals with a history of thrombosis / cardiovascular disease, endocrine disorders
  • Individuals with knee injuries (i.e., ACL injuries).
  • Individuals with a positive medical history of unstable thyroid disease (i.e., hypothyroidism, hyperthyroidism, hyperparathyroidism, and hypoparathyroidism) and immune disorders.
  • Individuals who have used tobacco products within the last 6 months.
  • Chronic usage of medications known to modulate hormone levels (i.e. corticosteroids and hormone replacement therapy (HRT)) in the last 6 months.
  • Current use of ketone supplements or adherence to a ketogenic diet.
  • Formal or regular weightlifting activity within the last year.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University

    Montreal, Quebec, H2W 1S4

Other trials in Canada

About this study

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

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.

Read more

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).

Read the 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.

Being tested
Ketone Monoester (KET), Flavour matched placebo drink (CON), Resistance Exercise
Keywords
Ketone bodies, Exogenous ketone supplements, Resistance exercise, Testosterone, Anabolic hormones, Ketone monoester
Medical subject headings
Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketone Monoester (KET)Dietary supplement

    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.

  • Flavour matched placebo drink (CON)Dietary supplement

    • Flavoured water (non-caloric bitter + citrus flavours)
  • Resistance ExerciseOther

    • 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.
Study groups in NCT06683547
Study groupRoleWhat they receive
Ketone Monoester (KET)Active comparatorKetone monoester supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate dosed based on participants' body weight (0.36g/kg body weight). The nutritional beverage will be consumed twice: 30 minutes prior to the exercise workout (t = -60 min) and immediately following the completion of the exercise protocol (t = 0 min).
Receives: Dietary Supplement: Ketone Monoester (KET); Other: Resistance Exercise
Placebo drinkPlacebo comparatorFlavoured water. Participants will consume this beverage twice: 30 minutes prior to the exercise workout (t = -60 min) and immediately following the completion of the exercise protocol (t = 0 min).
Receives: Dietary Supplement: Flavour matched placebo drink (CON); Other: Resistance Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve for testosterone concentration.

    Serum concentration of testosterone (nmol/l) and corresponding area under the curve (AUC), measured at baseline and over 4 hours into the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period

  2. Time-course data for testosterone concentration.

    Serum concentration of testosterone (nmol/l) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

Secondary outcomes (24)
  1. Area under the curve for growth hormone concentration

    Serum concentration of growth hormone (μmol/L) and corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period

  2. Time-course data for growth hormone concentration.

    Changes in serum concentration of growth hormone (μmol/L) measured at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  3. Area under the curve for insulin-like growth factor-1 (IGF-1) concentration

    Serum concentration of IGF-1 (nmol/L) and corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and 4 hours into the post-exercise recovery period

  4. Time-course data for IGF-1 concentration

    Changes in serum concentration of IGF-1 (nmol/L) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  5. Area under the curve for cortisol concentration.

    Serum concentration of cortisol (nmol/L) and its corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period.

  6. Time-course data for cortisol concentration.

    Changes in serum concentration of cortisol (nmol/L) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  7. Area under the curve for luteinizing hormone concentration

    Serum concentration of luteinizing hormone concentrations (IU/L) and corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and 4 hours into the post-exercise recovery period

  8. Time-course data for luteinizing hormone concentration

    Changes in serum concentration of luteinizing hormone concentrations (IU/L) measured at13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  9. Area under the curve for dehydroepiandrosterone (DHEA) concentration

    Serum concentration of DHEA (μmol/L) and corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and 4 hours into the post-exercise recovery period.

  10. Time-course data for DHEA concentration

    Changes in serum concentration of DHEA (μmol/L) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  11. Area under the curve for sex hormone-binding globulin (SHBG) concentration

    Serum concentration of SHBG (nmol/L) and corresponding area under the curve (AUC), measured at baseline and during the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period.

  12. Time-course data for SHBG concentration.

    Changes in serum concentration of SHBG (nmol/L) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  13. Area under the curve for progesterone concentration

    Serum concentration of progesterone (nmol/L) and its corresponding area under the curve (AUC), measured at baseline and during the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period.

  14. Time-course data for progesterone concentration.

    Changes in serum concentration of progesterone (nmol/L) measured at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  15. Area under the curve for estrogen concentration

    Serum estrogen concentration (pmol/mL) and corresponding area under the curve (AUC), measured at baseline and during the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period.

  16. Time-course data for estrogen concentration

    Changes in serum concentration for estrogen (pmol/mL) measured at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  17. Area under the curve for follicle stimulating hormone (FSH) concentration

    Serum concentration of FSH (IU/l) and corresponding area under the curve (AUC), measured at baseline and during the post-exercise recovery period.

    Measured: Baseline and over 4 hours into the post-exercise recovery period.

  18. Time-course data for FSH concentration.

    Changes in serum concentration for FSH (IU/l) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  19. Area under the curve for glucose concentration

    Plasma glucose concentration (mmol/L) and its corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and 4 hours into the post-exercise recovery period

  20. Time-course data for glucose concentration

    Changes in plasma glucose concentration (mmol/L) measured at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  21. Area under the curve for insulin concentration

    Plasma concentration of insulin (pmol/L) and corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and 4 hours into the post-exercise recovery period

  22. Time-course data for insulin concentration

    Changes in plasma concentration of insulin (pmol/L) measured at baseline and at 13 timepoints (t = -60, -45, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

  23. Area under the curve for β-HB concentrations

    Capillary blood β-OHB concentration (mmol/L) and corresponding area under the curve (AUC), measured at baseline and over the post-exercise recovery period.

    Measured: Baseline and 4 hours into the post-exercise and postprandial period

  24. Time-course data for β-HB concentrations

    Changes in capillary blood β-HB concentrations (mmol/L) measured at 12 timepoints (t = -60, -45, -30, 0, 15, 30, 60, 90, 120, 150, 180, 240 min).

    Measured: Baseline, 1 hour pre-exercise and 4-hours during the post-exercise recovery period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start6 Jan 2025
  3. Primary completion27 Jul 2025
  4. Study completion27 Jul 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06683547
Sponsor's protocol ID
A00-M69-24B
Status last verified
Jan 2025
First submitted
8 Nov 2024
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Ketone Monoester (KET) and Resistance Exercise in people with Ketosis and Blood Hormones, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve for testosterone concentration. (time frame: Baseline and over 4 hours into the post-exercise recovery period). The study lists 2 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 2 Sep 2025.

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