NCT01818609

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

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

July 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
Last Updated

February 25, 2020

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

July 19, 2011

Last Update Submit

February 21, 2020

Conditions

Keywords

sarcopeniamusclereduced activityinsulin sensitivityproteinstep reductionmuscle protein synthesiswhey proteinleg strengthwhole body protein

Outcome Measures

Primary Outcomes (1)

  • Fractional synthetic rate (FSR) of myofibrillar muscle protein

    rate of making new muscle proteins

    over 5h

Secondary Outcomes (3)

  • Blood amino acid concentrations

    over 5h

  • Intramuscular signalling protein status

    over 5h

  • Insulin sensitivity via blood sampling

    over 5h

Study Arms (1)

Step Reduction

EXPERIMENTAL

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

Behavioral: Step reduction

Interventions

Step reductionBEHAVIORAL

taking less than 1500 steps/d

Also known as: Sedentary behaviour
Step Reduction

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

SarcopeniaInsulin Resistance

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Stuart M Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

March 26, 2013

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

February 25, 2020

Record last verified: 2013-03

Locations