KetosisNCT04565444
Ketones and Muscle Protein Synthesis
A study testing Ketone, Ketone + Protein and Protein in people with Ketosis and Regulation of Muscle Protein Synthesis, run by McGill University at 1 site in Canada.
Trial summary
Ketones are natural substances normally produced by the body during prolonged fasting and starvation, or in response to a "ketogenic" diet to be used as fuel by the brain and muscles. Ketones are therefore similar to dietary proteins, carbohydrates and fats since they represent a source of energy for the body. 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
- Ketosis, Regulation of Muscle Protein Synthesis
- What is being tested?
- Ketone, Ketone + Protein and Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2020to 14 May 2021
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged between 18-35 years inclusive
- Healthy, moderately active
- BMI < 30 kg/m2 and > 18.5 kg/m2
- Having given informed consent
Who cannot join
- Presence of any identified metabolic or intestinal disorders
- Use of tobacco products
- Allergies to milk proteins (whey or casein)
- Lactose intolerance
- Phenylketonuria (PKU)
- A history of neuromuscular problems
Show all 12Show fewer
- Previous participation in amino acid tracer studies
- Adherence to a strict vegetarian or vegan diet
- Current use of ketone supplements or adherence to a ketogenic diet
- Use of medications known to affect protein metabolism
- Diagnosis of Diabetes
- Engagement in sports or physical exercise 5 or more days per week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism and Nutrition Research Laboratory
Montreal, Quebec, H2W 1S4
About this study
Official title: The Effects of Acute Nutritional Ketosis on Myofibrillar Protein Synthesis in Young Men
Ketones are natural substances normally produced by the body during prolonged fasting and starvation, or in response to a "ketogenic" diet to be used as fuel by the brain and muscles. Ketones are therefore similar to dietary proteins, carbohydrates and fats since they represent a source of energy for the body. In addition to serving as a source of energy, ketones have also been shown to stimulate increased rates of muscle protein synthesis in humans.
The ingestion of dietary protein is well established to stimulate an increase in the rate of protein synthesis in skeletal muscle. The rate of muscle protein synthesis can be maximized following the intake of 20g of protein. As a result, smaller doses of protein (i.e. 10g) represent a sub-optimal dose of protein because there is still room for improvement concerning muscle protein synthesis.
Read more
Recently ketone-containing food products have become available that elevate ketone levels in the body without the need for ketogenic diets or prolonged fasting. Therefore, the purpose of this study is to measure skeletal muscle protein synthesis rates after ingesting the following:
- Ketone monoester
- Ketone monoester supplemented with sub-optimal dose of whey protein
- Sub-optimal dose of whey protein
It is hypothesized that muscle protein synthesis rates will increase following the ingestion of a ketone-containing beverage. Further, muscle protein synthesis rates will be enhanced when the ketone-containing beverage and sub-optimal protein dose are taken together.
- Conditions
- Ketosis, Regulation of Muscle Protein Synthesis
- Being tested
- Ketone, Ketone + Protein, Protein
- Keywords
- ketone, protein metabolism, muscle
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoneDietary supplement
- Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
- Isocaloric carbohydrate control: dextrose + vanilla flavouring
Ketone + ProteinDietary supplement
- Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
- 10g Whey Protein
- L-[ring-2H5]-phenylalanine tracer (enriched to 4%)
ProteinDietary supplement
- Isocaloric carbohydrate control: dextrose + stevia
- 10g Whey Protein
- L-[ring-2H5]-phenylalanine tracer (enriched to 4%)
| Study group | Role | What they receive |
|---|---|---|
| Ketone | Experimental | Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and carbohydrate control. Receives: Dietary Supplement: Ketone |
| Ketone + Protein | Experimental | Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and 10g of whey protein. Receives: Dietary Supplement: Ketone + Protein |
| Protein | Experimental | Carbohydrate control and 10g of whey protein. Receives: Dietary Supplement: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Measured: 0-5 hours in the post-prandial period
Secondary outcomes (7)
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Measured: 0-3 hours in the pre-prandial period; 0-2 hours, and 2-5 hours into the post-prandial period
Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine
Measured: 3 hours pre-prandial to 5 hours post-prandial
Plasma glucose concentration (mmol/L)
Measured: 3 hours pre-prandial to 5 hours post-prandial
Plasma insulin concentration (pmol/L)
Measured: 3 hours pre-prandial to 5 hours post-prandial
Plasma amino acid concentrations (mmol/L)
Measured: 3 hours pre-prandial to 5 hours post-prandial
Capillary blood Beta-OHB concentrations (mmol/L)
Measured: 0-5 hours in the post-prandial period
Signaling molecule phosphorylation status
The use of Western blots to measure the phosphorylation status of signaling molecules involved in protein synthesis ie. mTOR, p70S6k, 4E-BP1
Measured: 0, 2, and 5 hours into the post-prandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start21 Sep 2020
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KetosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
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
- NCT04565444
- Sponsor's protocol ID
- A11-M51-19A
- Status last verified
- May 2021
- First submitted
- 17 Sep 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hannaian SJ, Lov J, Hawley SE, Dargegen M, Malenda D, Gritsas A, Gouspillou G, Morais JA, Churchward-Venne TA. Acute ingestion of a ketone monoester, whey protein, or their co-ingestion in the overnight postabsorptive state elicit a similar stimulation of myofibrillar protein synthesis rates in young males: a double-blind randomized trial. Am J Clin Nutr. 2024 Mar;119(3):716-729. doi: 10.1016/j.ajcnut.2024.01.004. Epub 2024 Jan 11.
PubMed 38215886
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Nutritional Ketosis on Myofibrillar Protein Synthesis in Young Men
- ClinicalTrials.gov ID
- NCT04565444
- Acronym / sponsor ID
- A11-M51-19A
- Conditions
- Ketosis, Regulation of Muscle Protein Synthesis
- Keywords
- ketone, protein metabolism, muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ketones are natural substances normally produced by the body during prolonged fasting and starvation, or in response to a "ketogenic" diet to be used as fuel by the brain and muscles. Ketones are therefore similar to dietary proteins, carbohydrates and fats since they represent a source of energy for the body. In addition to serving as a source of energy, ketones have also been shown to stimulate increased rates of muscle protein synthesis in humans.
The ingestion of dietary protein is well established to stimulate an increase in the rate of protein synthesis in skeletal muscle. The rate of muscle protein synthesis can be maximized following the intake of 20g of protein. As a result, smaller doses of protein (i.e. 10g) represent a sub-optimal dose of protein because there is still room for improvement concerning muscle protein synthesis.
Recently ketone-containing food products have become available that elevate ketone levels in the body without the need for ketogenic diets or prolonged fasting. Therefore, the purpose of this study is to measure skeletal muscle protein synthesis rates after ingesting the following:
- Ketone monoester
- Ketone monoester supplemented with sub-optimal dose of whey protein
- Sub-optimal dose of whey protein
It is hypothesized that muscle protein synthesis rates will increase following the ingestion of a ketone-containing beverage. Further, muscle protein synthesis rates will be enhanced when the ketone-containing beverage and sub-optimal protein dose are taken together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketone | Experimental | Dietary Supplement: KetoneKetone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and carbohydrate control. |
| Ketone + Protein | Experimental | Dietary Supplement: Ketone + ProteinKetone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and 10g of whey protein. |
| Protein | Experimental | Dietary Supplement: ProteinCarbohydrate control and 10g of whey protein. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Aged between 18-35 years inclusive
- Healthy, moderately active
- BMI < 30 kg/m2 and > 18.5 kg/m2
- Having given informed consent
Key exclusion criteria (12 listed)
- Presence of any identified metabolic or intestinal disorders
- Use of tobacco products
- Allergies to milk proteins (whey or casein)
- Lactose intolerance
- Phenylketonuria (PKU)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone* Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) * Isocaloric carbohydrate control: dextrose + vanilla flavouring | Dietary supplement | Ketone |
| Ketone + Protein* Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) * 10g Whey Protein * L-[ring-2H5]-phenylalanine tracer (enriched to 4%) | Dietary supplement | Ketone + Protein |
| Protein* Isocaloric carbohydrate control: dextrose + stevia * 10g Whey Protein * L-[ring-2H5]-phenylalanine tracer (enriched to 4%) | Dietary supplement | Protein |
Primary outcome
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Time frame: 0-5 hours in the post-prandial period
7 secondary outcomes
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Time frame: 0-3 hours in the pre-prandial period; 0-2 hours, and 2-5 hours into the post-prandial period
Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine
Time frame: 3 hours pre-prandial to 5 hours post-prandial
Plasma glucose concentration (mmol/L)
Time frame: 3 hours pre-prandial to 5 hours post-prandial
Plasma insulin concentration (pmol/L)
Time frame: 3 hours pre-prandial to 5 hours post-prandial
Plasma amino acid concentrations (mmol/L)
Time frame: 3 hours pre-prandial to 5 hours post-prandial
Capillary blood Beta-OHB concentrations (mmol/L)
Time frame: 0-5 hours in the post-prandial period
Signaling molecule phosphorylation status
Time frame: 0, 2, and 5 hours into the post-prandial period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 38215886Hannaian SJ, Lov J, Hawley SE, Dargegen M, Malenda D, Gritsas A, Gouspillou G, Morais JA, Churchward-Venne TA. Acute ingestion of a ketone monoester, whey protein, or their co-ingestion in the overnight postabsorptive state elicit a similar stimulation of myofibrillar protein synthesis rates in young males: a double-blind randomized trial. Am J Clin Nutr. 2024 Mar;119(3):716-729. doi: 10.1016/j.ajcnut.2024.01.004. Epub 2024 Jan 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler A Churchward-Venne, Ph.D. principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone, Ketone + Protein and Protein in people with Ketosis and Regulation of 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 12 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 18 May 2021. 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. 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?
Fractional synthetic rate of muscle protein synthesis (myofibrillar) (time frame: 0-5 hours in the post-prandial period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565444, which also lists 1 linked publication.
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 18 May 2021.