NCT02347137

Brief Summary

As the loss of muscle mass with aging is associated with a dysregulation of muscle protein synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients, the primary outcome of the trial is to investigate the effect of a mixed macronutrient beverage on post-prandial myofibrillar MPS. However, the 'anabolic resistance' of aging may be predominantly influenced by the contractile activity of skeletal muscle; for example, the investigators have demonstrated that 2 weeks of reduced habitual activity (i.e. daily step count) induces anabolic resistance in otherwise healthy older adults. In contrast, resistance exercise is well-known to enhance muscle mass and can increase the sensitivity of skeletal muscle to dietary amino acids. Therefore, all participants will undergo a 2-week reduced step count intervention combined with a unilateral leg resistance exercise protocol to induce an 'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or 'anabolically sensitive' leg, respectively; this within subject model will be utilized to investigate the effect of the mixed macronutrient beverage in both relatively 'healthy' and 'unhealthy' older muscle. The investigators will also measure changes in muscle mass, muscle function, and cardiovascular health of both legs before and after the 2-week intervention to determine the effect of reduced activity and the protective effect of minimal, low-intensity exercise on these outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

January 6, 2015

Last Update Submit

January 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar fractional synthetic rate will be measured using 13C6 ring phenylalanine

    analysis

    7 hours

Secondary Outcomes (3)

  • body composition (lean body mass, fat mass, leg lean mass, leg fat mass) will be measured using dual energy xray absorptiometry

    14 days

  • leg muscle strength (leg press and leg extension 1 repetition maximum [1-RM], peak knee extensor torque) will be measured using a dynamometer

    14 days

  • vascular function (femoral blood flow, femoral artery diameter, leg pulse) will be measured using doppler ultrasound

    14 days

Study Arms (3)

Isolated Whey Protein

ACTIVE COMPARATOR

20 g isolated whey protein + 15 g non-essential amino acids

Other: step-reductionOther: step-reduction plus resistance exercise

Micellar Whey Protein

EXPERIMENTAL

20 g micellar whey protein + 15 g non-essential amino acids

Other: step-reductionOther: step-reduction plus resistance exercise

Micellar Whey Protein + Citrulline

EXPERIMENTAL

20 g micellar whey protein + 5 g citrulline

Other: step-reductionOther: step-reduction plus resistance exercise

Interventions

reduce daily physical activity to less than 1500 steps per day

Isolated Whey ProteinMicellar Whey ProteinMicellar Whey Protein + Citrulline

reduce physical activity to less than 1500 steps per day with thrice weekly low-load, high effort resistance exercise

Isolated Whey ProteinMicellar Whey ProteinMicellar Whey Protein + Citrulline

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Non-smoker

You may not qualify if:

  • Health problems such as: heart disease, rheumatoid arthritis, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put the participant at risk for this study
  • Failed clearance for exercise participation by the participants family physician/medical doctor
  • Failed an exercise strength test.
  • Regular consumption of any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically will be excluded.
  • Taking any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
  • Factors that may exclude a participant from an MRI scan (i.e. various implants, metal in the eyes etc)
  • Participants who complete fewer than 5000 steps per day (as assessed by pedometer prior to the study).

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 (2)

  • Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.

    PMID: 23589526BACKGROUND
  • Burd NA, West DW, Moore DR, Atherton PJ, Staples AW, Prior T, Tang JE, Rennie MJ, Baker SK, Phillips SM. Enhanced amino acid sensitivity of myofibrillar protein synthesis persists for up to 24 h after resistance exercise in young men. J Nutr. 2011 Apr 1;141(4):568-73. doi: 10.3945/jn.110.135038. Epub 2011 Feb 2.

    PMID: 21289204BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 27, 2015

Study Start

July 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations