Post-exercise Period(KET-YOUNG-M)NCT07884539
Acute Effects of Ketone Monoester Co-ingestion With Dietary Protein on Whole-body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Young Males.
A study testing Ketone Monoester + Dietary Protein (KET+PRO), Dietary Protein (PRO) and Resistance Exercise in people with Post-exercise Period and Ketosis, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post-exercise Period, Ketosis, Resistance Exercise
- What is being tested?
- Ketone Monoester + Dietary Protein (KET+PRO), Dietary Protein (PRO) and Resistance Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 23 Oct 2026to 1 May 2027
- Phase
- Interventional
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
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
Exercise metabolism and Nutrition research Laboratory
Montreal, Quebec, H2W1S4
Nazmul H Bhuiyan, 6477876974, nakibcd@gmail.com
About this study
Official title: Acute Effects of Ketone Monoester Co-ingestion With Dietary Protein on Whole-Body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Young Males.
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.
Read the detailed description
Recent evidence suggests that ketone bodies may increase muscle protein synthesis rates and decrease muscle protein breakdown rates. Thus, our hypothesis is that ketone monoester supplementation combined with protein intake in the post-resistance exercise period will result in greater levels of phenylalanine retention and decreased phenylalanine oxidation relative to protein intake alone in the post-exercise period. In this randomized, double-blind placebo-controlled crossover study 18 healthy males aged 18-35 will perform a bout of whole-body resistance exercises then consume either the ketone + protein treatment or the protein control treatment. Participants will first complete a screening and familiarization visit to determine eligibility for the study. During this visit, anthropometric measurements such as height, body mass and body composition will be assessed. Participants will also be familiarized with all study procedures. Submaximal strength testing will be performed to estimate one-repetition maximum values for each exercise included in the protocol. Participants will be asked to refrain from strenuous physical activity and maintain consistent daily activity patterns for 48 hours prior to each testing session. A standardized diet will be provided for the 48 hour period leading up to each experimental trial, followed by an overnight fast of approximately 10 hours. In addition, the night prior to the experimental test-day subjects will consume a D3-3-methylhistidine tracer. Each participant will complete two experimental trials in a randomized, double-blind crossover design, separated by a washout period of approximately two weeks to allow for appropriate blood recovery and to minimize any potential carryover effects. On experimental test days, upon arrival at the laboratory, participants will rest and an initial blood draw and breath sample will be completed. A venous catheter will be inserted for repeated blood sampling following exercise. Participants will complete a supervised bout of whole-body resistance exercise consisting of multiple exercises targeting major muscle groups (i.e., chest, legs, shoulders, back, abs). Exercise intensity will be prescribed relative to each participant's estimated 1RM, at 80% of that value. Following the exercise bout, participants will consume one of the experimental nutritional treatments according to their randomized assignment. These treatments will include a combination of protein and ketone monoester or protein alone to serve as a control. All beverages will be matched for volume, taste and appearance to maintain blinding. The beverages will also contain 13-C labelled phenylalanine as a tracer for phenylalanine metabolism. Following ingestion of the experimental beverage, participants will remain in the laboratory for a recovery period of six hours. During this time, repeated blood and breath samples will be collected at regular intervals to assess whole-body phenylalanine oxidation, phenylalanine retention and myofibrillar protein breakdown. Throughout the experimental visit, participants will remain fasted except for the consumption of the test beverage and will have access to water as needed.
- Conditions
- Post-exercise Period, Ketosis, Resistance Exercise, Dietary Protein
- Being tested
- Ketone Monoester + Dietary Protein (KET+PRO), Dietary Protein (PRO), Resistance Exercise
- Keywords
- Ketosis, Resistance Exercise, Men, Dietary protein, Ketone bodies, Beta-Hydroxybutyrate, Post-exercise period, Protein oxidation
- Medical subject headings
- Ketosis, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester + Dietary Protein (KET+PRO)Dietary supplement
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)Dietary supplement
Protein at a dose of 0.3 g/kg body weight protein in the form of whey protein hydrolysate.
Resistance ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketone Monoester + Dietary Protein (KET+PRO) | Experimental | 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. Receives: Dietary Supplement: Ketone Monoester + Dietary Protein (KET+PRO); Other: Resistance Exercise |
| Dietary Protein (PRO) | Placebo comparator | 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. Receives: Dietary Supplement: Dietary Protein (PRO); Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine Oxidation
Quantification of whole-body phenylalanine oxidation using 13CO2 enrichment measured in breath samples following ingestion of labeled phenylalanine.
Measured: 0-360 minutes in the postprandial period
Phenylalanine Retention
Quantification of whole-body phenylalanine retention calculated as the difference between phenylalanine intake and total exogenous phenylalanine oxidation following ingestion of labeled phenylalanine.
Measured: 0-360 minutes in the postprandial period
Secondary outcomes (15)
Incremental area under the curve for total amino acid concentration
Incremental area under the curve for plasma total amino acid concentrations (mmol/L), including: histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, proline, serine and tyrosine , measured from repeated blood samples collected throughout 1-hour pre-prandial period and 6-hour postprandial recovery period
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for total amino acid concentration
Changes in plasma concentration of total amino acid concentration (μmol/L) including: free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline (combined), measured at 18 time points (t = -60, 0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 270, 300, 330, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Incremental area under the curve for essential amino acid concentration
Incremental area under the curve (iAUC) for plasma essential amino acid concentration (μmol/L) including free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined), measured across the 1-hour pre-prandial period and 6-hour postprandial period.
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for essential amino acid concentration
Changes in plasma concentration of essential amino acid (μmol/L) including: free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined), measured at 18 time points (t = -60, 0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 270, 300, 330, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Incremental area under the curve for branched chain amino acid concentration
Incremental area under the curve (iAUC) for plasma branched chain amino acid concentration (μmol/L) including free leucine, isoleucine and valine measured across the 1-hour pre-prandial period and 6-hour postprandial period.
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for branched chain amino acid concentration
Changes in plasma concentration of branched chain amino acid (μmol/L) including: free leucine, isoleucine and valine measured at 18 time points (t = -60, 0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 270, 300, 330, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Incremental area under the curve for leucine concentration
Incremental area under the curve (iAUC) for plasma leucine concentration (μmol/L) measured across the 1-hour pre-prandial period and 6-hour postprandial period.
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for leucine concentration
Changes in plasma concentration of leucine (μmol/L) measured at 18 time points (t = -60, 0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 270, 300, 330, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Plasma insulin incremental area under the curve
Incremental area under the curve for plasma insulin concentrations (mmol/L), measured from repeated blood samples collected throughout the 1-hour pre-prandial period and 6-hours postprandial recovery period.
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for insulin concentration
Changes in plasma concentration of insulin (pmol/L) measured at 18 time points (t = -60, 0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 270, 300, 330, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Plasma glucose incremental area under the curve
Incremental area under the curve for plasma glucose concentrations (mmol/L), measured from repeated blood samples collected throughout the 1-hour pre-prandial period and 6-hours postprandial recovery period.
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for glucose concentration
Changes in plasma concentration of glucose (mmol/L) measured at 18 time points (t = -60, 0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 270, 300, 330, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Capillary blood β-hydroxybutyrate incremental area under the curve
Incremental area under the curve for capillary blood β-hydroxybutyrate concentrations (mmol/L), measured using capillary blood samples collected throughout the 1-hour pre-prandial period and 6-hours postprandial recovery period.
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Time-course data for capillary β-HB concentrations
Changes in capillary blood β-OHB concentration (mmol/L) measured at 9 time points (t = -60, 0, 30, 60, 120, 180, 240, 300, 360 minutes).
Measured: 60 minutes pre-prandial to 360 minutes postprandial
Whole-body myofibrillar protein breakdown rate
Quantification of whole-body myofibrillar protein breakdown rate during the 6-hour postprandial recovery period using D3-3MH tracer consumed 18 hours before start of test day.
Measured: 0-360 minutes in the postprandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start23 Oct 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-exercise PeriodStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Churchward-Venne, McGill University
- Investigators
- Tyler A Churchward-Venne, Ph.D, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884539
- Sponsor's protocol ID
- 26-03-001
- Acronym
- (KET-YOUNG-M)
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No