NCT02371278

Brief Summary

The loss of muscle mass with aging is associated with a dysregulation of muscle protein synthesis (MPS) that is generally characterized by a suppressed MPS response to protein ingestion. This 'anabolic resistance' to protein feeding can be overcome with the ingestion of larger protein servings (\~0.4g/kg/meal, equivalent to \~ 30 - 40g/meal); however, older adults would likely find it challenging to consume such quantities of protein on a per meal basis. The amino acid leucine has a unique role as a key 'activator' of MPS. Some research shows that increasing the leucine content of a suboptimal dose of a protein supplement can enhance the MPS response in older adults. However it is currently unknown whether the co-ingestion of leucine with normal, mixed meals can increase MPS. Furthermore, it has been suggested that leucine supplementation may only benefit older adults consuming suboptimal daily protein intakes. Therefore, the purpose of the current study is to examine the impact of leucine co-ingestion with mixed macronutrient meals on the myofibrillar protein synthetic response in older men consuming daily protein intakes at or below the current recommendations. A further objective is to determine whether the myofibrillar protein synthetic response to a session of resistance exercise is enhanced by leucine supplementation with meals. The investigators hypothesize that, in both the exercised and non-exercised condition, leucine co-ingestion at meals will enhance integrative myofibrillar protein synthesis in older adults consuming lower daily protein intakes, but will not augment MPS in those consuming higher daily protein. The investigators further hypothesize that the influence of leucine supplementation on MPS will be greater in the exercise condition than the non-exercise condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

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

First Submitted

Initial submission to the registry

February 13, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

February 13, 2015

Last Update Submit

March 14, 2016

Conditions

Keywords

LeucineProteinDietMuscle protein synthesis

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar protein fractional synthetic rate

    The incorporation of a stable isotope (deuterium) into muscle tissue will allow for the determination of fractional synthetic rate, which is indicative of muscle protein synthesis.

    3 days

Secondary Outcomes (3)

  • Aminoacidemia in response to daily meals with and without leucine supplementation

    3 days

  • Glycaemia in response to daily meals with and without leucine supplementation

    3 days

  • Insulinemia in response to daily meals with and without leucine supplementation

    3 days

Study Arms (2)

Higher daily protein

OTHER

Diets will provide protein intakes of 1.2 g/kg/d. Placebo with meals for 3 days, and leucine with meals for 3 days.

Dietary Supplement: LeucineDietary Supplement: Placebo

Lower daily protein

OTHER

Diets will provide protein intakes of 0.8 g/kg/d. Placebo with meals for 3 days, and leucine with meals for 3 days.

Dietary Supplement: LeucineDietary Supplement: Placebo

Interventions

LeucineDIETARY_SUPPLEMENT

5 g leucine with sucrose and maltodextrin

Higher daily proteinLower daily protein
PlaceboDIETARY_SUPPLEMENT

5 g glycine with sucrose and maltodextrin

Higher daily proteinLower daily protein

Eligibility Criteria

Age65 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Body mass index (BMI) between 20-35 kg/m2
  • Non-smokers

You may not qualify if:

  • Diabetes mellitus, prediabetes and the metabolic syndrome
  • Cardiovascular disease
  • Neuromuscular problems or muscle wasting diseases
  • Renal disease
  • Gastrointestinal disease
  • Musculoskeletal conditions such as rheumatoid arthritis or osteoarthritis
  • Infectious disease
  • Cancer
  • Significant body mass loss in the 1 month period prior to the study
  • Vegetarianism
  • Use of medications known to interfere with muscle metabolism (i.e. beta-blockers, high dose non-steroidal anti-inflammatory drugs, corticosteroids, hormone replacement therapy, antiarrhythmic drugs, warfarin, prescription strength acne medications, oral hypoglycaemic agents and insulin)
  • Regular resistance training or daily step counts \>9,000 or \<3,500

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Murphy CH, Saddler NI, Devries MC, McGlory C, Baker SK, Phillips SM. Leucine supplementation enhances integrative myofibrillar protein synthesis in free-living older men consuming lower- and higher-protein diets: a parallel-group crossover study. Am J Clin Nutr. 2016 Dec;104(6):1594-1606. doi: 10.3945/ajcn.116.136424. Epub 2016 Nov 9.

MeSH Terms

Conditions

Sarcopenia

Interventions

Leucine

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Stuart M. Phillips, Ph.D. FACN, FACSM

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 25, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations