Study of Inactivity on Metabolism of Elderly Muscles
Primary Purpose
Sarcopenia
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Step reduction
Sponsored by
About this trial
This is an interventional basic science trial for Sarcopenia focused on measuring sarcopenia, muscle, reduced activity, insulin sensitivity, protein, step reduction, muscle protein synthesis, whey protein, leg strength, whole body protein
Eligibility Criteria
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:
- 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
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Step Reduction
Arm Description
Step reduction: Take less than 1500 steps/d No disease
Outcomes
Primary Outcome Measures
Fractional synthetic rate (FSR) of myofibrillar muscle protein
rate of making new muscle proteins
Secondary Outcome Measures
Blood amino acid concentrations
concentration of amino acids in blood
Intramuscular signalling protein status
phosphorylation of key signalling proteins
Insulin sensitivity via blood sampling
measure of insulin concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01818609
Brief Title
Study of Inactivity on Metabolism of Elderly Muscles
Official Title
Influence of Reduce Daily Step Count on Muscle Protein Metabolism in Older Persons
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, muscle, reduced activity, insulin sensitivity, protein, step reduction, muscle protein synthesis, whey protein, leg strength, whole body protein
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Step Reduction
Arm Type
Experimental
Arm Description
Step reduction:
Take less than 1500 steps/d
No disease
Intervention Type
Behavioral
Intervention Name(s)
Step reduction
Other Intervention Name(s)
Sedentary behaviour
Intervention Description
taking less than 1500 steps/d
Primary Outcome Measure Information:
Title
Fractional synthetic rate (FSR) of myofibrillar muscle protein
Description
rate of making new muscle proteins
Time Frame
over 5h
Secondary Outcome Measure Information:
Title
Blood amino acid concentrations
Description
concentration of amino acids in blood
Time Frame
over 5h
Title
Intramuscular signalling protein status
Description
phosphorylation of key signalling proteins
Time Frame
over 5h
Title
Insulin sensitivity via blood sampling
Description
measure of insulin concentration
Time Frame
over 5h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart M Phillips, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Inactivity on Metabolism of Elderly Muscles
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