Recruiting

D3-Creatine

Sponsor:

McMaster University

Code:

NCT06630949

Conditions

Aging

Muscle Loss

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06630949

Start date

Oct 1, 2023

Status verified date

Oct, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Muscle mass [ Time Frame: 2 years ]
  • Lean tissue mass [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Shalini Jaisankar Sumathi, MS

905-525-9140jaisans@mcmaster.ca

Locations

Exercise Metabolism Research Laboratory, McMaster Univeristy

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

Stuart M Phillips, Ph.D.

905-525-9140phillis@mcmaster.ca

Principal Investigator:

Stuart M Phillips, Ph.D.

More Information

Sponsor

McMaster University

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-10-08.