Ketones and Muscle Protein Synthesis

NCT04565444 | Completed

• 1 other identifier: A11-M51-19A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Ketone monoester
2. 2.Ketone monoester supplemented with sub-optimal dose of whey protein
3. 3.Sub-optimal dose of whey protein

Conditions

Ketosis; Regulation of Muscle Protein Synthesis

Keywords

ketone; protein metabolism; muscle

Outcome Measures

Primary Outcomes (1)

• Fractional synthetic rate of muscle protein synthesis (myofibrillar)

  0-5 hours in the post-prandial period

Secondary Outcomes (7)

• 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 glucose concentration (mmol/L)

  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

Study Arms (3)

Ketone

EXPERIMENTAL

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

Dietary Supplement: Ketone

Ketone + Protein

EXPERIMENTAL

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

Dietary Supplement: Ketone + Protein

Protein

EXPERIMENTAL

Carbohydrate control and 10g of whey protein.

Dietary Supplement: Protein

Interventions

Ketone 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

Ketone + Protein 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%)

Ketone + Protein

Protein DIETARY_SUPPLEMENT

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

Protein

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged between 18-35 years inclusive
• Healthy, moderately active
• BMI \< 30 kg/m2 and \> 18.5 kg/m2
• Having given informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Exercise Metabolism and Nutrition Research Laboratory

Montreal, Quebec, H2W 1S4, Canada

Location

Related Publications (1)

• 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.

  PMID: 38215886 DERIVED

MeSH Terms

Conditions

Ketosis

Interventions

Ketones; Proteins

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Amino Acids, Peptides, and Proteins

Study Officials

• Tyler A Churchward-Venne, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tyler A. Churchward-Venne, Ph.D., Assistant Professor, McGill University

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 25, 2020
• Study Start: September 21, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

CA (1)