NCT01492010

Brief Summary

Muscle mass is normally maintained through the regulated balance between the processes of protein synthesis (i.e. making new muscle proteins) and protein breakdown (breaking down old muscle proteins). Proteins are composed of amino acids and we know that amino acids increase muscle protein synthesis. However, not all amino acids are the same. Essential amino acids are ones that must be consumed through food, while non-essential amino acids can be made by our body. Interestingly, the essential amino acids are all that are required to increase the rate of muscle protein synthesis. In addition, the essential amino acid leucine appears to be particularly important in regulating protein synthesis. However, how leucine is able to increase protein synthesis is not entirely understood. Previously, it has been shown that 20-25 g of high-quality protein, such as that found in milk, appears to be the amount of protein that maximizes the rate of muscle protein synthesis after performing a bout of resistance exercise. Thus, the aim is to measure the synthesis of new muscle proteins after ingesting the following:

  1. 1.25g whey protein
  2. 2.6.25g whey protein supplemented with leucine
  3. 3.6.25g whey protein supplemented with essential amino acids but no leucine

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

December 12, 2011

Last Update Submit

February 21, 2020

Conditions

Keywords

skeletal muscleFSRresistance exerciseleucineprotein

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (= intracellular availability).

    5 hours postprandial

Secondary Outcomes (1)

  • Signaling molecule phosphorylation status

    1, 3, and 5 hours

Study Arms (3)

25 g protein

EXPERIMENTAL

25 g whey protein

Dietary Supplement: whey protein

6.25 g protein supplemented with leucine

EXPERIMENTAL

6.25 g protein supplemented with leucine

Dietary Supplement: whey protein supplemented with leucine

6.25 g whey protein with EAA

EXPERIMENTAL

6.25 g protein supplemented with a mixture of essential amino acids devoid of leucine

Dietary Supplement: whey protein supplemented with essential amino acids

Interventions

whey proteinDIETARY_SUPPLEMENT

25 g whey protein

Also known as: whey protein powder
25 g protein

6.25 g whey protein supplemented with free form leucine

Also known as: whey protein powder supplemented with free-form leucine
6.25 g protein supplemented with leucine

6.25 g whey protein supplemented with essential amino acids devoid of leucine

Also known as: whey protein supplemented with EAA devoid of leucine
6.25 g whey protein with EAA

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • years of age
  • non-smoker/ non-tobacco product user

You may not qualify if:

  • heart disease
  • vascular disease
  • rheumatoid arthritis
  • diabetes
  • poor lung function
  • uncontrolled blood pressure
  • dizziness
  • thyroid problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Churchward-Venne TA, Burd NA, Mitchell CJ, West DW, Philp A, Marcotte GR, Baker SK, Baar K, Phillips SM. Supplementation of a suboptimal protein dose with leucine or essential amino acids: effects on myofibrillar protein synthesis at rest and following resistance exercise in men. J Physiol. 2012 Jun 1;590(11):2751-65. doi: 10.1113/jphysiol.2012.228833. Epub 2012 Mar 25.

MeSH Terms

Interventions

Whey ProteinsLeucineAmino Acids, Essential

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAmino Acids, Branched-ChainAmino Acids

Study Officials

  • Stuart M Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations