NCT04565444

Ketones and Muscle Protein Synthesis

Completed NA Last updated 18 May 2021

What this trial tests

NA trial testing Ketone in Ketosis in 36 participants. Completed in 14 May 2021.

Timeline

21 September 2020

Primary endpoint
14 May 2021

14 May 2021

Quick facts

Lead sponsor	McGill University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	36
Start date	21 September 2020
Primary completion	14 May 2021
Estimated completion	14 May 2021
Sites	1 location across Canada

Drugs / interventions tested

• Ketone — full drug profile →
• Ketone + Protein
• Protein

Conditions studied

• Ketosis — all drugs for Ketosis →
• Regulation of Muscle Protein Synthesis — all drugs for Regulation of Muscle Protein Synthesis →

Sponsor

McGill University

Who can join

Adults 18 to 35, male only, with Ketosis or Regulation of Muscle Protein Synthesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Hannaian SJ, Lov J, Hawley SE, Dargegen M, et al · · 2024 · cited 8× · PMID 38215886 · DOI 10.1016/j.ajcnut.2024.01.004
2. Acute effects of a ketone monoester, whey protein, or their coingestion on mTOR trafficking and protein-protein colocalization in human skeletal muscle.
   Hannaian SJ, Lov J, Cheng-Boivin Z, Abou Sawan S, et al · · 2024 · cited 6× · PMID 38682238 · DOI 10.1152/ajpcell.00207.2024