Ketones and Muscle Protein Synthesis

NCT ID: NCT04565444

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Ketosis Regulation of Muscle Protein Synthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketone

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

Group Type EXPERIMENTAL

Ketone

Intervention Type 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

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

Group Type EXPERIMENTAL

Ketone + Protein

Intervention Type 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

Carbohydrate control and 10g of whey protein.

Group Type EXPERIMENTAL

Protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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%)

Intervention Type DIETARY_SUPPLEMENT

Protein

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Tyler Churchward-Venne

Tyler A. Churchward-Venne, Ph.D., Assistant Professor, McGill University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tyler A Churchward-Venne, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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Exercise Metabolism and Nutrition Research Laboratory

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Hannaian SJ, Lov J, Hawley SE, Dargegen M, Malenda D, Gritsas A, Gouspillou G, Morais JA, Churchward-Venne TA. Acute ingestion of a ketone monoester, whey protein, or their co-ingestion in the overnight postabsorptive state elicit a similar stimulation of myofibrillar protein synthesis rates in young males: a double-blind randomized trial. Am J Clin Nutr. 2024 Mar;119(3):716-729. doi: 10.1016/j.ajcnut.2024.01.004. Epub 2024 Jan 11.

Reference Type DERIVED
PMID: 38215886 (View on PubMed)

Other Identifiers

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A11-M51-19A

Identifier Type: -

Identifier Source: org_study_id

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