Ketones and Muscle Protein Synthesis
Primary Purpose
Ketosis, Regulation of Muscle Protein Synthesis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ketone
Ketone + Protein
Protein
Sponsored by
About this trial
This is an interventional treatment trial for Ketosis focused on measuring ketone, protein metabolism, muscle
Eligibility Criteria
Inclusion Criteria:
- Male
- Aged between 18-35 years inclusive
- Healthy, moderately active
- BMI < 30 kg/m2 and > 18.5 kg/m2
- Having given informed consent
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Exercise Metabolism and Nutrition Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ketone
Ketone + Protein
Protein
Arm Description
Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and carbohydrate control.
Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and 10g of whey protein.
Carbohydrate control and 10g of whey protein.
Outcomes
Primary Outcome Measures
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Secondary Outcome Measures
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine
Plasma glucose concentration (mmol/L)
Plasma insulin concentration (pmol/L)
Plasma amino acid concentrations (mmol/L)
Capillary blood Beta-OHB concentrations (mmol/L)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04565444
Brief Title
Ketones and Muscle Protein Synthesis
Official Title
The Effects of Acute Nutritional Ketosis on Myofibrillar Protein Synthesis in Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Regulation of Muscle Protein Synthesis
Keywords
ketone, protein metabolism, muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone
Arm Type
Experimental
Arm Description
Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and carbohydrate control.
Arm Title
Ketone + Protein
Arm Type
Experimental
Arm Description
Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and 10g of whey protein.
Arm Title
Protein
Arm Type
Experimental
Arm Description
Carbohydrate control and 10g of whey protein.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone + Protein
Intervention Description
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%)
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
Isocaloric carbohydrate control: dextrose + stevia
10g Whey Protein
L-[ring-2H5]-phenylalanine tracer (enriched to 4%)
Primary Outcome Measure Information:
Title
Fractional synthetic rate of muscle protein synthesis (myofibrillar)
Time Frame
0-5 hours in the post-prandial period
Secondary Outcome Measure Information:
Title
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
Title
Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine
Time Frame
3 hours pre-prandial to 5 hours post-prandial
Title
Plasma glucose concentration (mmol/L)
Time Frame
3 hours pre-prandial to 5 hours post-prandial
Title
Plasma insulin concentration (pmol/L)
Time Frame
3 hours pre-prandial to 5 hours post-prandial
Title
Plasma amino acid concentrations (mmol/L)
Time Frame
3 hours pre-prandial to 5 hours post-prandial
Title
Capillary blood Beta-OHB concentrations (mmol/L)
Time Frame
0-5 hours in the post-prandial period
Title
Signaling molecule phosphorylation status
Description
The use of Western blots to measure the phosphorylation status of signaling molecules involved in protein synthesis ie. mTOR, p70S6k, 4E-BP1
Time Frame
0, 2, and 5 hours into the post-prandial period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
Aged between 18-35 years inclusive
Healthy, moderately active
BMI < 30 kg/m2 and > 18.5 kg/m2
Having given informed consent
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler A Churchward-Venne, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Metabolism and Nutrition Research Laboratory
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Ketones and Muscle Protein Synthesis
We'll reach out to this number within 24 hrs