Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630949
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
D3-Creatine and Skeletal Muscle in Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using a Novel Method to Diagnose the Prevalence and Health Impact of Muscle Loss in Older Adults
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
D3-Cr
Brief Summary:
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 eg 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
Detailed Description:
The tools currently employed to assess skeletal muscle mass SMM including DXA have substantial drawbacks DXA does not measure muscle per se but provides an assessment of lean soft tissue LST as a proxy for skeletal muscle Even if confined to the appendages aLST DXA assessments include many non-muscle constituents eg connective tissue water which are poorly and inconsistently related to mobility and falls with aging As a superior measure to DXA the investigators will use a novel stable isotope-labelled probe to measure SMM This method uses the oral ingestion of a small dose of deuterium D-labelled creatine D3-creatine D3-Cr which is irreversibly converted to creatinine when taken up by skeletal muscle The dilution of the labelled creatinine provides a safe non-invasive and highly accurate measure of SMM The utilization of D3-Cr-measured SMM D3-Cr-SMM requires no specific diet and requires only the collection of a spot urine sample
The plan is to recruit a sub-sample of older Canadians between 60 and 80 living in the greater Hamilton-Toronto area Participants will be recruited through the MacM3 M3 cohort study MacM3 will enroll a sample of 2000 participants from a pre-recruited representative sample of more than 10000 older adults living in the greater Hamilton and Toronto areas who consented to be contacted for further research as part of a larger research platform From this pool of 2000 individuals in MacM3 the plan is to recruit 350 people Participants will be classified across the three levels of mobility limitations based on the MacM3 screening criteria of preclinical mobility limitation ie able to manage without difficulty - no mobility limitation able to manage without difficulty but sometimes with task modification - early mobility limitation and able to manage with minor difficulty - minor mobility limitation which will provide valuable insight into whether changes in D3-Cr-SMM are associated with a change in categorical mobility status
The proposed research design is a prospective cohort study including 350 older 65-80 y men and women All participants will undergo muscle mass assessments via D3-Cr body composition LST aLST fat mass via DXA and dietary intake by 24h recall ASA24 at baseline 1y and 2y of follow-up Performance-based assessments of physical function mobility status and muscular strength will also be conducted at baseline 1y and 2y of follow-up During the quarterly follow-up phone calls all participants will be screened limitation screening questions see inclusion criteria allowing us to capture changes in mobility status ie no early minor or major mobility limitation over time
The plan is to recruit a sub-sample of older Canadians between 60 and 80 living in the greater Hamilton-Toronto area Participants will be recruited through the MacM3 M3 cohort study MacM3 will enroll a sample of 2000 participants from a pre-recruited representative sample of more than 10000 older adults living in the greater Hamilton and Toronto areas who consented to be contacted for further research as part of a larger research platform From this pool of 2000 individuals in MacM3 the plan is to recruit 350 people Participants will be classified across the three levels of mobility limitations based on the MacM3 screening criteria of preclinical mobility limitation ie able to manage without difficulty - no mobility limitation able to manage without difficulty but sometimes with task modification - early mobility limitation and able to manage with minor difficulty - minor mobility limitation which will provide valuable insight into whether changes in D3-Cr-SMM are associated with a change in categorical mobility status
The proposed research design is a prospective cohort study including 350 older 65-80 y men and women All participants will undergo muscle mass assessments via D3-Cr body composition LST aLST fat mass via DXA and dietary intake by 24h recall ASA24 at baseline 1y and 2y of follow-up Performance-based assessments of physical function mobility status and muscular strength will also be conducted at baseline 1y and 2y of follow-up During the quarterly follow-up phone calls all participants will be screened limitation screening questions see inclusion criteria allowing us to capture changes in mobility status ie no early minor or major mobility limitation over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None