Ketones and Muscle Protein Synthesis

Sponsor
McGill University (Other)
Overall Status
Completed
CT.gov ID
NCT04565444
Collaborator
(none)
36
1
3
7.7
4.7

Study Details

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:

  1. Ketone monoester

  2. Ketone monoester supplemented with sub-optimal dose of whey protein

  3. 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ketone
  • Dietary Supplement: Ketone + Protein
  • Dietary Supplement: Protein
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Acute Nutritional Ketosis on Myofibrillar Protein Synthesis in Young Men
Actual Study Start Date :
Sep 21, 2020
Actual Primary Completion Date :
May 14, 2021
Actual Study Completion Date :
May 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ketone

Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and carbohydrate control.

Dietary Supplement: 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

Experimental: Ketone + Protein

Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and 10g of whey protein.

Dietary Supplement: 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%)

Experimental: Protein

Carbohydrate control and 10g of whey protein.

Dietary Supplement: Protein
Isocaloric carbohydrate control: dextrose + stevia 10g Whey Protein L-[ring-2H5]-phenylalanine tracer (enriched to 4%)

Outcome Measures

Primary Outcome Measures

  1. Fractional synthetic rate of muscle protein synthesis (myofibrillar) [0-5 hours in the post-prandial period]

Secondary Outcome Measures

  1. Fractional synthetic rate of muscle protein synthesis (myofibrillar) [0-3 hours in the pre-prandial period; 0-2 hours, and 2-5 hours into the post-prandial period]

  2. Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine [3 hours pre-prandial to 5 hours post-prandial]

  3. Plasma glucose concentration (mmol/L) [3 hours pre-prandial to 5 hours post-prandial]

  4. Plasma insulin concentration (pmol/L) [3 hours pre-prandial to 5 hours post-prandial]

  5. Plasma amino acid concentrations (mmol/L) [3 hours pre-prandial to 5 hours post-prandial]

  6. Capillary blood Beta-OHB concentrations (mmol/L) [0-5 hours in the post-prandial period]

  7. Signaling molecule phosphorylation status [0, 2, and 5 hours into the post-prandial period]

    The use of Western blots to measure the phosphorylation status of signaling molecules involved in protein synthesis ie. mTOR, p70S6k, 4E-BP1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Exercise Metabolism and Nutrition Research Laboratory Montreal Quebec Canada H2W 1S4

Sponsors and Collaborators

  • McGill University

Investigators

  • Principal Investigator: Tyler A Churchward-Venne, Ph.D., McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tyler Churchward-Venne, Tyler A. Churchward-Venne, Ph.D., Assistant Professor, McGill University, McGill University
ClinicalTrials.gov Identifier:
NCT04565444
Other Study ID Numbers:
  • A11-M51-19A
First Posted:
Sep 25, 2020
Last Update Posted:
May 18, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tyler Churchward-Venne, Tyler A. Churchward-Venne, Ph.D., Assistant Professor, McGill University, McGill University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2021