Ketones and Muscle Protein Synthesis

Ketosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565444
• Other study ID #: A11-M51-19A
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: May 14, 2021

Study information

• Verified date: May 2021
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketosis
• Regulation of Muscle Protein Synthesis

Intervention

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

Locations

Country	Name	City	State
Canada	Exercise Metabolism and Nutrition Research Laboratory	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional synthetic rate of muscle protein synthesis (myofibrillar)		0-5 hours in the post-prandial period
Secondary	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
Secondary	Plasma enrichments (in moles percent excess) of L-[ring-2H5]-phenylalanine		3 hours pre-prandial to 5 hours post-prandial
Secondary	Plasma glucose concentration (mmol/L)		3 hours pre-prandial to 5 hours post-prandial
Secondary	Plasma insulin concentration (pmol/L)		3 hours pre-prandial to 5 hours post-prandial
Secondary	Plasma amino acid concentrations (mmol/L)		3 hours pre-prandial to 5 hours post-prandial
Secondary	Capillary blood Beta-OHB concentrations (mmol/L)		0-5 hours in the post-prandial period
Secondary	Signaling molecule phosphorylation status	The use of Western blots to measure the phosphorylation status of signaling molecules involved in protein synthesis ie. mTOR, p70S6k, 4E-BP1	0, 2, and 5 hours into the post-prandial period