NCT01885429

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 (whey), appears to be the amount of protein that maximizes the rate of muscle protein synthesis after performing a bout of resistance exercise. Thus, we aim to measure the synthesis of new muscle proteins after ingesting different amounts of protein and amino acids. We will measure muscle protein synthesis after consumption of the beverage a participant is randomized to in a leg that has done no exercise ( ie. a rested leg) and in the other leg that has done resistance exercise. Amino acids are 'strung-together' to make protein. The 'essential' amino acids must be consumed through food because our body cannot make them, thus they are consumed when you eat protein rich foods like milk or chicken. Leucine, isoleucine, and valine are simply 3 of the 8 essential amino acids that make up dietary protein. Unlike essential amino acids, 'non-essential' amino acids may be synthesized by the body, however they are also present in protein rich foods like chicken or milk. We aim to determine if it is the leucine content found in 25 g of whey protein that is primarily responsible for maximizing muscle protein synthesis at rest and following resistance exercise. We also wish to determine how muscle genes and metabolism respond to this protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

April 23, 2013

Last Update Submit

July 26, 2013

Conditions

Keywords

Protein TurnoverResistance ExerciseWhey ProteinLeucine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in myofibrillar protein synthesis

    Myofibrillar protein synthesis will be determined by the standard precursor-product method as described previously and routinely measured and published.

    In the first 1.5h after exercise/feeding and from 1.5-4.5h after exercise/feeding

Study Arms (5)

Positive Control

EXPERIMENTAL

Group 1 (Positive(+) Control) will receive: 25g of whey protein. Positive Control

Dietary Supplement: Positive Control

Negative Control

EXPERIMENTAL

Group 2 (Negative(-) Control) will receive: 6.25g whey. Negative Control

Dietary Supplement: Negative Control

Low Protein + Low Leucine Spike

EXPERIMENTAL

Group 3 (Low Protein + Low Leucine Spike) will receive: 6.25g whey + low added leucine. Low Protein Low Leucine Spike

Dietary Supplement: Low Protein Low Leucine Spike

Low Protein + High Leucine Spike

EXPERIMENTAL

Group 4 (Low Protein + High Leucine Spike) will receive: 6.25g whey + high added leucine. Low Protein High Leucine Spike

Dietary Supplement: Low Protein High Leucine Spike

Low Protein + High Leucine + BCAA Spike

EXPERIMENTAL

Group 5 (Low Protein + High Leucine + BCAA Spike) will receive: 6.25g whey + added branched-chain amino acids. Low Protein + High Leucine + BCAA Spike

Dietary Supplement: Low Protein + High Leucine + BCAA Spike

Interventions

Positive ControlDIETARY_SUPPLEMENT

Subject consumes 25g of whey protein following unilateral exercise

Positive Control
Negative ControlDIETARY_SUPPLEMENT

Subject consumes 6.25g of whey protein following unilateral exercise

Negative Control

Subject consumes 6.25g of whey protein plus 3g of leucine following unilateral exercise

Low Protein + Low Leucine Spike

Subject consumes 6.25g of whey protein plus 5g of leucine following unilateral exercise

Low Protein + High Leucine Spike

Subject consumes 6.25g of whey protein plus 5g of leucine plus valine and isoleucine (BCAA) following unilateral exercise

Low Protein + High Leucine + BCAA Spike

Eligibility Criteria

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

You may qualify if:

  • Male
  • Healthy and physically active (as determined by medical and activity questionnaire)
  • years of age
  • kg body mass
  • Having given informed consent

You may not qualify if:

  • Exhibiting health risk factors as identified on the health screening questionnaire
  • Having any identified metabolic or intestinal disorders
  • Tobacco use
  • Aspirin use in the 4 days prior to the experimental trial
  • Consumption of prescription medications or any performance enhancing agent
  • Inability to endure the strenuous exercise bouts e.g. injuries
  • Alcohol intake during the 48 hours prior to each of the testing days
  • Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
  • Have given blood in the last three weeks
  • Verbal confirmation that they have used a substance on the WADA banned list within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Interventions

Diet, Protein-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Stuart M Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

June 25, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations