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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04565444
Other study ID # A11-M51-19A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2020
Est. completion date May 14, 2021

Study information

Verified date May 2021
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 14, 2021
Est. primary completion date May 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Ketosis
  • Regulation of Muscle Protein Synthesis

Intervention

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

Locations

Country Name City State
Canada Exercise Metabolism and Nutrition Research Laboratory Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional synthetic rate of muscle protein synthesis (myofibrillar) 0-5 hours in the post-prandial period
Secondary 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
Secondary Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine 3 hours pre-prandial to 5 hours post-prandial
Secondary Plasma glucose concentration (mmol/L) 3 hours pre-prandial to 5 hours post-prandial
Secondary Plasma insulin concentration (pmol/L) 3 hours pre-prandial to 5 hours post-prandial
Secondary Plasma amino acid concentrations (mmol/L) 3 hours pre-prandial to 5 hours post-prandial
Secondary Capillary blood Beta-OHB concentrations (mmol/L) 0-5 hours in the post-prandial period
Secondary 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 0, 2, and 5 hours into the post-prandial period
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