Clinical trial NCT04565444: Ketones and Muscle Protein Synthesis
Official title: The Effects of Acute Nutritional Ketosis on Myofibrillar Protein Synthesis in Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Regulation of Muscle Protein Synthesis
Keywords: ketone
protein metabolism
muscle
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fractional synthetic rate of muscle protein synthesis (myofibrillar)
timeFrame: 0-5 hours in the post-prandial period
Secondary outcomes:
measure: Fractional synthetic rate of muscle protein synthesis (myofibrillar)
timeFrame: 0-3 hours in the pre-prandial period; 0-2 hours, and 2-5 hours into the post-prandial period
measure: Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine
timeFrame: 3 hours pre-prandial to 5 hours post-prandial
measure: Plasma glucose concentration (mmol/L)
timeFrame: 3 hours pre-prandial to 5 hours post-prandial
measure: Plasma insulin concentration (pmol/L)
timeFrame: 3 hours pre-prandial to 5 hours post-prandial
measure: Plasma amino acid concentrations (mmol/L)
timeFrame: 3 hours pre-prandial to 5 hours post-prandial
measure: Capillary blood Beta-OHB concentrations (mmol/L)
timeFrame: 0-5 hours in the post-prandial period
measure: Signaling molecule phosphorylation status
timeFrame: 0, 2, and 5 hours into the post-prandial period
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Exercise Metabolism and Nutrition Research Laboratory
state: Quebec
Study officials:
affiliation: McGill University
name: Tyler A Churchward-Venne, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: