AzTrials
AzTrials

KetosisNCT06769100

Exogenous Ketosis and Muscle Protein Synthesis During Exercise Recovery

A study testing Ketone Monoester (KET), Ketone Monoester + Whey Protein (KET+PRO) and Whey Protein (PRO) in people with Ketosis and Muscle Protein Synthesis, 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
Search all trials

Trial summary

An acute bout of resistance exercise stimulates muscle protein synthesis (MPS) rates for up to 24-48 hours, supporting muscle growth and repair. To optimize the anabolic effects of resistance exercise, the provision of dietary amino acids (i.e., proteins) is essential. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
Ketone Monoester (KET), Ketone Monoester + Whey Protein (KET+PRO) and Whey Protein (PRO)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteCanada
Study dates
10 Jan 2025to 2 Mar 2026
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult female or male participants who are 18-40 years of age (inclusive) BMI >18.5 and <30.0 kg/m2
  • Moderately active (i.e., ≥ 1 session of lower-body weightlifting /week for the previous 2 months).
  • 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 48hr prior to the experimental test day.
  • 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

  • Females who are lactating or pregnant
  • Females using third-generation oral contraceptives (including: Desogen®, Ortho-Cept, Ortho-Cyclen, Ortho Tri-Cyclen) as these are known to affect protein metabolism in females.
  • Individuals with metabolic disorders including: Type I or Type II diabetes
  • Individuals with a history of thrombosis / cardiovascular disease
  • Individuals who use of anticoagulants
  • Individuals with musculoskeletal / orthopedic disorders
Show all 17Show fewer
  • Individuals with knee injuries (i.e., ACL injuries).
  • Individuals who have used tobacco products within the last 6 months
  • Individuals with a history of neuromuscular problems
  • Chronic usage of medications known to modulate skeletal muscle metabolism (i.e. corticosteroids, hormone replacement therapy (HRT), and over-the-counter supplements including creatine monohydrate) in the last 6 months.
  • Individuals with allergies to milk proteins (whey or casein).
  • Individuals with lactose intolerance
  • Individuals with Phenylketonuria (PKU)
  • Previous participation in amino acid tracer studies.
  • Adherence to a vegetarian or vegan diet
  • Current use of ketone supplements or adherence to a ketogenic diet
  • Individuals who train more than ≥ 5 sessions of lower-body weightlifting /week for the previous 4 months

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 Effects of Ketone Monoester Intake on Postprandial Myofibrillar Protein Synthesis Rates in Young Adults During Recovery Following an Acute Bout of Resistance Exercise

An acute bout of resistance exercise stimulates muscle protein synthesis (MPS) rates for up to 24-48 hours, supporting muscle growth and repair. To optimize the anabolic effects of resistance exercise, the provision of dietary amino acids (i.e., proteins) is essential. Dietary protein intake provides the body with necessary amounts of essential and non-essential amino acids, which represent the building blocks for muscle proteins, enhancing anabolic muscle growth. The ingestion of dietary protein, such as whey protein, is well established to stimulate an increase in the rate of protein synthesis in skeletal muscle following resistance exercise. Research has demonstrated a dose-dependent relationship between protein intake and MPS rate, with 25 grams being the optimal dose to maximally stimulate MPS rates in younger adults with excess protein oxidized as a fuel source.

Determining whether this maximally stimulated MPS response can be further heightened during post-exercise recovery using non-protein dietary factors is yet to be explored. Recently, it has been shown that novel orally ingested ketone body supplements can stimulate MPS rates in younger adults at rest.

Read more

Ketone bodies (β-OHB) are lipid- derived molecules normally produced under conditions of glucose deprivation (i.e., fasting/starvation, or a low carbohydrate 'ketogenic' diet). However, these orally ingested ketone supplements rapidly increase blood ketone levels without the need for dietary restriction6. In vitro research showed that the combination of leucine and ketone bodies stimulated a 2-fold increase in MPS, compared to the leucine group alone, indicating synergistic effects of protein and ketone bodies on MPS. However, the effect of ketone supplementation, with and without dietary protein co-ingestion, on MPS rate during post-exercise recovery is yet to be investigated. If ketone bodies can amplify the anabolic response to dietary protein, they may provide a novel approach to maximizing muscle adaptation during post-exercise recovery.

Therefore, the purpose of this study is to evaluate the effects of ketone monoester intake on postprandial muscle protein synthesis rates when consumed alone and when co-ingested with an optimal dose (25 g) of whey protein during recovery after resistance exercise compared to 1) an optimal dose of whey protein (25 g), and 2) a control flavored water. It is hypothesized that muscle protein synthesis rates will be stimulated following the ingestion of the ketone body beverage. Further, muscle protein synthesis rates will be further enhanced when the ketone-containing beverage and an optimal dose are taken together.

Read the detailed description

A parallel group design will be used for this randomized double-blind, placebo-controlled study in healthy adults to investigate the effects of ketone monoester on myofibrillar protein synthesis rates during post-exercise recovery. There are 4 groups in this trial, including one ketone group (0.36g/kg body weight) (KET), one protein group (25 g whey protein) (PRO), a combination of ketone and protein (KET+PRO), and a placebo group (flavoured water) (CON). A total of 48 participants will be enrolled in this trial (n=12 per group).

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 the exercise protocol, and the experimental trial (visit 3).

During the experimental trials, participants will arrive to the laboratory in a fasted state, and a prime dose of the L-[ring-2H5]-phenylalanine will be administered followed by a continuous infusion at a rate 0.05 μmol/kg of body weight/min. Then, participants will perform a unilateral lower-body resistance exercise, consisting of 8 sets of 10 reps of unilateral leg extension at 90% of their 10-RM with 90 seconds rest in between sets. Following exercise, the nutritional treatment will be administered.

Arterialized blood will be collected at baseline and 13 postprandial timepoints across 9 hours for plasma amino acid, glucose, and insulin quantitation.

Additionally, changes in capillary blood β-HB concentration will be assessed throughout the trial by collecting capillary blood samples at baseline and 10 postprandial timepoints. Finally, muscle biopsy samples from both the exercised leg and the rested leg will be collected prior to beverage intake and at the 5-hour mark of the postprandial post-recovery period to assess myofibrillar protein synthesis rates.

Being tested
Ketone Monoester (KET), Ketone Monoester + Whey Protein (KET+PRO), Whey Protein (PRO), Flavour matched placebo (CON), Resistance exercise
Keywords
Ketosis, Regulation of Muscle Protein Synthesis, Resistance Exercise, Post-Exercise Recovery, Whey Protein
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
  • Ketone Monoester + Whey Protein (KET+PRO)Dietary supplement

    • Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
    • 25g Whey Protein
    • L-[ring-2H5]-phenylalanine tracer (enriched to 4%)
  • Whey Protein (PRO)Dietary supplement

    • 25g Whey Protein
    • L-[ring-2H5]-phenylalanine tracer (enriched to 4%)
  • Flavour matched placebo (CON)Dietary supplement

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

    • 8 sets of 10 reps at 90% of 10- repetition maximum (10-RM) of unilateral leg extension with 90 seconds rest in between sets.
Study groups in NCT06769100
Study groupRoleWhat they receive
Ketone Monoester (KET)ExperimentalKetone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight).
Receives: Dietary Supplement: Ketone Monoester (KET); Other: Resistance exercise
Ketone Monoester + Whey Protein (KET+PRO)ExperimentalKetone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and 25g of whey protein.
Receives: Dietary Supplement: Ketone Monoester + Whey Protein (KET+PRO); Other: Resistance exercise
Whey Protein (PRO)Experimental25g of whey protein.
Receives: Dietary Supplement: Whey Protein (PRO); Other: Resistance exercise
Placebo drink (CON)Placebo comparatorFlavoured water.
Receives: Dietary Supplement: Flavour matched placebo (CON); Other: Resistance exercise

What is being measured

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

  1. Myofibrillar fractional synthesis rate

    Quantification of changes in basal myofibrillar fractional synthetic rate (%/hour) in the rested and exercised limbs.

    Measured: 0 - 5 hours in the postprandial period.

Secondary outcomes (14)
  1. Time-course data for plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine

    Changes in plasma-free L-[ring-2H5]-phenylalanine enrichment measured at 14 time points (t = -180, -120, -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: Baseline, 3 hours pre-prandial, and 5 hours into the postprandial period.

  2. Incremental area under the curve for total amino acid concentration

    Incremental area under the curve (iAUC) for plasma concentration of total amino acids (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 baseline and across the 3-hour pre-prandial period and 5-hour postprandial period.

    Measured: 3 hours pre-prandial to 5 hours postprandial

  3. 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 14 time points (t = -180, -120, -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: Baseline, 3 hours pre-prandial, and 5 hours into the postprandial period.

  4. 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 at baseline and across the 3-hour pre-prandial period and 5-hour postprandial period.

    Measured: 3 hours pre-prandial to 5 hours postprandial

  5. 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 14 time points (t = -180, -120, -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: Baseline, 3 hours pre-prandial, and 5 hours into the postprandial period.

  6. Incremental area under the curve for leucine concentration

    Incremental area under the curve (iAUC) for plasma leucine concentration (μmol/L) measured at baseline and across the 3-hour pre-prandial period and 5-hour postprandial period.

    Measured: 3 hours pre-prandial to 5 hours postprandial

  7. Time-course data for leucine concentration

    Changes in plasma concentration of leucine (μmol/L) measured at 14 time points (t = -180, -120, -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: Baseline, 3 hours pre-prandial, and 5 hours into the postprandial period.

  8. Incremental area under the curve for glucose concentration

    Plasma glucose concentration (mmol/L) and its corresponding incremental area under the curve (iAUC), measured at baseline and across the 3-hour pre-prandial period and 5-hour postprandial period.

    Measured: 3 hours pre-prandial to 5 hours post-prandial

  9. Time-course data for glucose concentration

    Changes in plasma concentration of glucose (mmol/L) measured at 14 time points (t = -180, -120, -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: Baseline, 3 hours pre-prandial, and 5 hours into the postprandial period.

  10. Incremental area under the curve for insulin concentration

    Incremental area under the curve (iAUC) for plasma concentration of insulin (pmol/L), measured at baseline and across the 3-hour pre-prandial period and 5-hour postprandial period.

    Measured: 3 hours pre-prandial to 5 hours post-prandial

  11. Time-course data for insulin concentration

    Changes in plasma concentration of insulin (pmol/L) measured at 14 time points (t = -180, -120, -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: Baseline, 3 hours pre-prandial, and 5 hours into the postprandial period.

  12. Incremental area under the curve for β-HB concentrations

    Capillary blood β-OHB concentration (mmol/L) and its corresponding incremental area under the curve (iAUC) measured during the pre-prandial period and postprandial period.

    Measured: 1 hour pre-prandial to 5 hours postprandial

  13. Time-course data for β-HB concentrations

    Changes in capillary blood β-OHB concentration (mmol/L) measured at 10 time points (t = -60, 0, 30, 60, 90, 120, 150, 180, 240, 300 minute).

    Measured: 1 hour pre-prandial to 5 hours in the post-prandial period

  14. Changes in the phosphorylation status of anabolic signaling molecules

    Western blot analysis will be used to measure the changes in the basal phosphorylation status of anabolic signaling molecules, including p-mTORC1 (Ser2448), p-p70S6K (Thr389), p-Akt (Ser473), p-4E-BP1 (Thr37/46), and p-rpS6 (Ser240/244), p-ERK1(Thr202/Tyr204), and p-ERK2 (Thr185/Tyr187), in the exercised and the rested limbs.

    Measured: 0 and 5 hours of the postprandial period.

Timeline

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

  1. First posted10 Jan 2025
  2. Study start10 Jan 2025
  3. Primary completion2 Mar 2026
  4. Study completion2 Mar 2026

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769100
Sponsor's protocol ID
A00-M15-24A
Status last verified
Mar 2026
First submitted
6 Jan 2025
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ketone Monoester (KET), Ketone Monoester + Whey Protein (KET+PRO) and Whey Protein (PRO) in people with Ketosis and Muscle Protein Synthesis, 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 5 inclusion and 17 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 23 Mar 2026. 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?

Myofibrillar fractional synthesis rate (time frame: 0 - 5 hours in the postprandial period.). 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 23 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in