Recruiting

Ketone Monoester & Protein

Sponsor:

McGill University

Code:

NCT07884539

Conditions

Post-exercise Period

Ketosis

Resistance Exercise

Dietary Protein

Eligibility Criteria

Sex: Male

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Ketone Monoester + Dietary Protein (KET+PRO)

Dietary Protein (PRO)

Resistance Exercise

Study Details

Brief summary:

The goal of this trial is to determine if ketone monoester supplementation in conjunction with protein supplementation in the post exercise period can augment whole-body protein metabolism following resistance exercise in young trained males. This trial will compare the difference in phenylalanine metabolism between the ketone monoester and control conditions. Secondary outcomes including plasma amino acid, plasma insulin, plasma glucose, capillary blood beta-hydroxybutyrate concentrations and whole body myofibrillar protein breakdown rate (k) will be explored as secondary measures. Ketone monoester supplementation with protein in the post-resistance exercise period will be compared to the control condition of just protein in the post-resistance exercise period.

Conditions

Post-exercise Period

Ketosis

Resistance Exercise

Dietary Protein

Study ID

NCT07884539

Start date

Oct 23, 2026

Status verified date

Oct, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult male aged 18-35 at time of initial screening.
  • Generally healthy (no uncontrolled diseases or conditions) as determined by health history, and if necessary, physician clearance.
  • BMI between 18.5 and 30 kg·m-2 (inclusive) at time of initial screening.
  • Maintenance of a stable body weight for at least 3 months prior to participation and willingness to maintain this weight during the duration of this study
  • Maintained stable use of medication and supplements (which are not limited by the exclusion criteria), and stable dietary and lifestyle habits for the last 3 months prior to screening and agree to maintain them throughout the study
  • Minimum 6 months of resistance training experience with a minimum of 2 sessions/week
  • Able and willing to understand and agree to the requirements and restrictions of this study and provide written informed consent

Exclusion Criteria:

  • Presence of cardiovascular, metabolic, renal, hepatic, neuromuscular, or gastrointestinal disease that could interfere with study participation or data interpretation or make the resistance training unsafe
  • History of severe cardiovascular events (myocardial infarction, stroke, severe hypertension)
  • Any musculoskeletal injury that would prevent completion of the resistance exercise protocol
  • Ketone supplementation or adherence to a ketogenic diet
  • Use of medication known to influence protein metabolism
  • Participation in a stable-isotope tracer study in the past 6 months
  • Tobacco/nicotine use
  • Undergoing exercise sessions more than 5 days/week.
  • Metal implants
  • Paralysis, limb loss, or congenital or acquired absence of skeletal muscle
  • Individuals with Phenylketonuria (PKU)
  • Dairy allergy or lactose intolerance

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketone Monoester + Dietary Protein (KET+PRO)

0.36 g/kg body weight of Ketone monoester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate and 0.3 g of protein/kg body weight from whey protein hydrolysate dissolved in 250 mL of sugar-free Powerade with the addition of stevia and bitters to improve and homogenize taste between treatments.

placebo comparator: Dietary Protein (PRO)

0.3 g of protein/kg body weight from whey protein hydrolysate dissolved in 250 mL of sugar-free Powerade with the addition of stevia and bitters to homogenize taste between treatments.

Interventions

Ketone Monoester + Dietary Protein (KET+PRO)

Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight). Protein at a dose of 0.3 g/kg body weight protein. The protein component will come from whey protein hydrolysate.

Dietary Protein (PRO)

Protein at a dose of 0.3 g/kg body weight protein in the form of whey protein hydrolysate.

Resistance Exercise

Full body exercise session consisting of a 5 minute treadmill run and 5 minute multi-joint stretch session consisting of a pectoral stretch, latissimus dorsi stretch, a quadriceps stretch and a hamstring stretch followed by the following exercises: machine chest press, machine seated row, machine shoulder press, machine quadriceps extension, machine hamstrings curl, and machine abdominal crunch performed for 3 sets of 8 repetitions each performed at 80% of 1RM, with 2 repetitions in reserve.

Primary outcome measure

  • Phenylalanine Oxidation [ Time Frame: 0-360 minutes in the postprandial period ]
  • Phenylalanine Retention [ Time Frame: 0-360 minutes in the postprandial period ]

Central Contacts and Locations

Central contacts

Tyler A Churchward-Venne, Ph.D

514-399-9684tyler.churchward-venne@mcgill.ca

Nazmul H Bhuiyan, BHSc

647-787-6974nazmul.bhuiyan@mail.mcgill.ca

Locations

Exercise metabolism and Nutrition research Laboratory

Recruiting

Montreal, Quebec, Canada, H2W1S4

Contacts

Nazmul H Bhuiyan

6477876974nakibcd@gmail.com

More Information

Sponsor

McGill University

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Ketosis
  • Resistance Exercise
  • Men
  • Dietary protein
  • Ketone bodies
  • Beta-Hydroxybutyrate
  • Post-exercise period
  • Protein oxidation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by McGill University on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.