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CompletedNCT01818609Updated Feb 25, 2020

Study of Inactivity on Metabolism of Elderly Muscles

A Phase 1 interventional study of Step reduction in Sarcopenia, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by McMaster University · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
60 Years to 80 Years
Sex
All
01

Study summary

Skeletal muscle mass declines with inactivity (casting is a good example) and increases with activity (such as weightlifting). Whether muscle mass increases or decreases, is determined by whether more new proteins within muscle are made than are broken down. The investigators know that feeding protein increases the synthesis of new proteins but that the response of older muscles to protein feeding is blunted compared with the young. This resistance of the elderly to muscle building stimuli may be the primary reason that muscle mass is lost in aging. The investigators also know that periods of muscle disuse such as casting result in a person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at approximately 1% for every year after. Elderly persons would likely fare well with advancing age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is a 'population view' and does not represent what occurs during short periods of muscle disuse (i.e. during hospitalization or illness), which occur with increasing frequency in elderly persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may be worsened. The investigators will measure how quickly new proteins are made at rest and after protein feeding in elderly men, before and after a 14 day period of reduced activity brought on by having people reduce their daily step count.

02

Conditions studied

  • Sarcopenia

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Keywords

  • sarcopenia
  • muscle
  • reduced activity
  • insulin sensitivity
  • protein
  • step reduction
  • muscle protein synthesis
  • whey protein
  • leg strength
  • whole body protein
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or Female
  • Aged 60 to 80 years old
  • Non-smoker Generally healthy and can tolerate the resistance exercise and protein drink

Exclusion criteria

Exclusion Criteria:

  • Allergies to whey protein
  • Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
  • Failed an exercise stress test
  • Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
  • Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
  • Taking medications for lung and kidney conditions but excluding medication for asthma that is under control
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Step Reduction

    Step reduction: * Take less than 1500 steps/d * No disease

    Behavioral: Step reduction

Interventions

  • BehavioralStep reduction

    taking less than 1500 steps/d

    Also known as: Sedentary behaviour

06

What researchers measure

Primary outcomes

  1. Fractional synthetic rate (FSR) of myofibrillar muscle protein

    rate of making new muscle proteins

    Time frame: over 5h

Secondary outcomes

  1. Blood amino acid concentrations

    concentration of amino acids in blood

    Time frame: over 5h

  2. Intramuscular signalling protein status

    phosphorylation of key signalling proteins

    Time frame: over 5h

  3. Insulin sensitivity via blood sampling

    measure of insulin concentration

    Time frame: over 5h

07

Study locations

1 site
  • McMaster University
    Hamilton, Ontario L8S 4K1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01818609
Lead sponsor
McMaster University
Responsible party
Sponsor
First posted
Mar 26, 2013
Start date
Sep 2011
Primary completion
Sep 2012
Completion
Dec 2012
Last update
Feb 25, 2020

Study contacts

Stuart M Phillips, PhD
principal investigator · McMaster University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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