An interventional study of Ketone Monoester + Dietary Protein (KET+PRO) and Dietary Protein (PRO) in Post-exercise Period, Ketosis and Resistance Exercise, sponsored by McGill University. Recruiting at 1 site in Canada. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by McGill University · Not applicable, Interventional, and Basic science
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.
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.
195 studies on the registry are indexed under Ketosis; 41 are open to participants now.
This study's planned enrollment of 18 is below the median of 24 across 156 interventional studies indexed under Ketosis.
Browse Ketosis studies →McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Ketone Monoester + Dietary Protein (KET+PRO) · Other: Resistance Exercise
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.
Dietary Supplement: Dietary Protein (PRO) · Other: Resistance Exercise
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.
Protein at a dose of 0.3 g/kg body weight protein in the form of whey protein hydrolysate.
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.
Phenylalanine Oxidation
Quantification of whole-body phenylalanine oxidation using 13CO2 enrichment measured in breath samples following ingestion of labeled phenylalanine.
Time frame: 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.
Time frame: 0-360 minutes in the postprandial period
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
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 0-360 minutes in the postprandial period
Plan to share: No
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Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 5 months after the start.
Of 76 non-industry interventional studies with no phase under Ketosis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's planned 5 months is below that.
Counting every sponsor, half of 79 studies reached it within 14 months; a quarter within 7 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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