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Ketones and Muscle Protein Synthesis

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McGill University

Status

Completed

Conditions

Regulation of Muscle Protein Synthesis
Ketosis

Treatments

Dietary Supplement: Ketone
Dietary Supplement: Protein
Dietary Supplement: Ketone + Protein

Study type

Interventional

Funder types

Other

Identifiers

NCT04565444
A11-M51-19A

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36 participants in 3 patient groups

Ketone
Experimental group
Description:
Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight) and carbohydrate control.
Treatment:
Dietary Supplement: Ketone
Ketone + Protein
Experimental group
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.
Treatment:
Dietary Supplement: Ketone + Protein
Protein
Experimental group
Description:
Carbohydrate control and 10g of whey protein.
Treatment:
Dietary Supplement: Protein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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