D3-Creatine and Skeletal Muscle in Older Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorMcMaster University
About this trial
The age-related decline in muscle mass and strength are collectively referred to as sarcopenia. However, the tools currently employed to assess skeletal muscle mass (SMM) (e.g., Dual-energy Xray Absorptiometry; DXA) have substantial drawbacks, and it is known that DXA-lean soft tissue (LST) is generally not associated with health outcomes of interest. Thus, the investigators propose using a novel, non-invasive, stable isotope-labelled probe (Deuterium (D)-labelled creatine (D3-creatine; D3-Cr)) to measure skeletal muscle mass in a large cohort of older individuals. The development and employment of new methods to accurately quantify the biological substrate of sarcopenia, skeletal muscle, are critical for the measure to remain clinically relevant. The plan is to measure 350 persons from the recently established (M3) prospective cohort. There will be measurement of lean soft tissue LST and appendicular LST (aLST) using DXA and compared to D3-Cr-measured SMM (D3-Cr-SMM) at baseline, 12mo, and 24mo (2yr) of follow-up. Physical mobility will also be measured (using various instruments).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between 60 and 80y (inclusive),
Reside in the local (i.e., within 60km of Hamilton) community; and
Are willing and able to provide written informed consent.
Walking 800m;
Disqualifiers
Participants who self-report more than minor difficulty will be considered to have a mobility disability and excluded.
Participants who cannot speak or read English will also be excluded.
Trial population
The cohort will be a sub-sample from the McMaster Monitoring My Mobility (MacM3) cohort, a newly founded research cohort. The MacM3 cohort is a longitudinal study of community-dwelling older Canadians (age 60-80 y at baseline) with different levels of mobility limitation (i.e., able to manage without difficulty - no mobility limitation; able to manage without difficulty but with task modification - early mobility limitation; and able to manage with minor difficulty - minor mobility limitation) collecting detailed mobility and health data on participants over two years of follow-up.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Muscle mass
D3-creatine-measured muscle mass
Time frame
2 years2
Lean tissue mass
DXA-measured lean tissue mass
Time frame
2 yearsSecondary outcomes
1
Questionnaire Mobility
Questionnaire-based assessment of participant's physical mobility
Time frame
2 years2
SPPB
Short physical performance battery (SPPB)
Time frame
2 years3
Timed up and go
Participant starts in a seated position, stands up upon go signal, walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov