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Completed

NCT Number: NCT04565444

Ketones and Muscle Protein Synthesis

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Exercise Metabolism and Nutrition Research Laboratory

Montreal, Quebec, H2W 1S4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketone

Dietary 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 + Protein

Dietary 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%)

Protein

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

Primary outcomes

  1. Fractional synthetic rate of muscle protein synthesis (myofibrillar)

    Time frame: 0-5 hours in the post-prandial period

Secondary outcomes

  1. 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

  2. Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine

    Time frame: 3 hours pre-prandial to 5 hours post-prandial

  3. Plasma glucose concentration (mmol/L)

    Time frame: 3 hours pre-prandial to 5 hours post-prandial

  4. Plasma insulin concentration (pmol/L)

    Time frame: 3 hours pre-prandial to 5 hours post-prandial

  5. Plasma amino acid concentrations (mmol/L)

    Time frame: 3 hours pre-prandial to 5 hours post-prandial

  6. Capillary blood Beta-OHB concentrations (mmol/L)

    Time frame: 0-5 hours in the post-prandial period

  7. Signaling molecule phosphorylation status

    Time frame: 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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

The Effects of Acute Nutritional Ketosis on Myofibrillar Protein Synthesis in Young Men

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 25, 2020
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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