Ketones and Muscle Protein Synthesis

Not Applicable

Completed

• Conditions: Ketosis; Regulation of Muscle Protein Synthesis
• Interventions: Dietary Supplement: Ketone; Dietary Supplement: Ketone + Protein; Dietary Supplement: Protein

• Registration Number: NCT04565444
• Lead Sponsor: McGill University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study Start: 2020-09-21
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Status Verified: 2021-05
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fractional synthetic rate of muscle protein synthesis (myofibrillar)	0-5 hours in the post-prandial period

Secondary Outcome Measures

Name	Time	Method
Capillary blood Beta-OHB concentrations (mmol/L)	0-5 hours in the post-prandial period
Fractional synthetic rate of muscle protein synthesis (myofibrillar)	0-3 hours in the pre-prandial period; 0-2 hours, and 2-5 hours into the post-prandial period
Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine	3 hours pre-prandial to 5 hours post-prandial
Plasma insulin concentration (pmol/L)	3 hours pre-prandial to 5 hours post-prandial
Plasma amino acid concentrations (mmol/L)	3 hours pre-prandial to 5 hours post-prandial
Signaling molecule phosphorylation status	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
Plasma glucose concentration (mmol/L)	3 hours pre-prandial to 5 hours post-prandial

Trial Locations

Locations (1)

Exercise Metabolism and Nutrition Research Laboratory; 🇨🇦 Montreal, Quebec, Canada