D3-Creatine and Skeletal Muscle in Older Adults

NCT06630949 | Recruiting

• 1 other identifier: 14733
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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) (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).

Conditions

Aging; Muscle Loss

Keywords

aging; muscle; stable isotope tracer; mobility; sarcopenia; creatine; creatinine

Outcome Measures

Primary Outcomes (2)

• Muscle mass

  D3-creatine-measured muscle mass

  2 years

• Lean tissue mass

  DXA-measured lean tissue mass

  2 years

Secondary Outcomes (3)

• Questionnaire Mobility

  2 years

• SPPB

  2 years

• Timed up and go

  2 years

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Participants will be considered eligible for this study if they are
• 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.
• Participants must fall into one of three self-reported mobility limitations based on validated screening criteria via a structured phone interview. Potential participants will be asked whether they have any difficulty:
• Walking 800m;
• Climbing ten steps; and
• Transferring from/into a car or bus.
• Response options include:
• Managing without difficulty;
• Managing without difficulty but with task modification; or
• Managing with minor difficulty.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine and bloodspot

MeSH Terms

Conditions

Muscular Atrophy; Sarcopenia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Stuart Phillips

  McMaster University, Department of Kinesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalini Jaisankar Sumathi, MS

CONTACT

905-525-9140; jaisans@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Canada Research Chair

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

CA (1)