NCT05810272

Brief Summary

The purpose of this study is to assess the impact of 3-days reduced physical activity (\<1500 steps/day) with/without 'exercise snacks' (15 chair stands with calf raises every 30 min) on skeletal muscle metabolic health.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

February 21, 2023

Last Update Submit

July 11, 2023

Conditions

Inactivity, PhysicalAgingHealthy AgingSarcopeniaMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Keywords

Skeletal MuscleStep-ReductionAgingAnabolic ResistancePhysical ActivityStable Isotopes

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar protein synthesis rates

    Myofibrillar protein synthesis rates assessed by incorporation of oral stable isotope tracer in both arms.

    5 Hours

Secondary Outcomes (4)

  • Whole-body protein turnover

    5 Hours

  • Amino acid oxidation and net protein balance

    5 Hours

  • Postprandial insulin area under the curve (AUC) to mixed macronutrient breakfast

    5 Hours postprandial

  • Postprandial glucose area under the curve (AUC) to mixed macronutrient breakfast

    5 hours postprandial

Study Arms (2)

Habitual Activity

OTHER

Following three days of habitual activity, a metabolic trial will be completed wherein participants (10M/10F) will be assessed for their anabolic response to a protein-carbohydrate meal.

Behavioral: Metabolic Trial

Step-Reduction

EXPERIMENTAL

Participants will undergo three days of reduced physical activity (\<1,500 steps/day) prior to a metabolic trial to establish their anabolic response to a protein-carbohydrate meal.

Behavioral: Metabolic TrialBehavioral: 15 sit-to-stands with calf raises

Interventions

Metabolic TrialBEHAVIORAL

Participants will undergo a metabolic trial to assess for their anabolic response to a protein-carbohydrate meal.

Habitual ActivityStep-Reduction
15 sit-to-stands with calf raisesBEHAVIORAL

Participants (n=10; 5F/5M) will be randomized to perform 15 sit-to-stands with calf raises every 30 minutes for the 4 hour duration between muscle biopsies

Also known as: Exercise Snacks
Step-Reduction

Eligibility Criteria

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

You may qualify if:

  • Healthy older (age: 60-80 y) adults
  • BMI between normal to overweight (18.5-29.9 kg/m2)

You may not qualify if:

  • Regular use of nonsteroidal anti-inflammatory drugs (with the exception of daily low-dose aspirin)
  • Alcohol consumption during the study period
  • Use of anticoagulants
  • Use of a walker, cane, or assistive walking device
  • Current or recently remised cancer
  • Infectious or gastrointestinal disease
  • Inability to comply with study protocol (e.g., \>1,500 steps/day during Step-Reduction Phase)
  • Regular tobacco use
  • Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
  • Diagnosed chronic illness (e.g. type 2 diabetes, heart disease, thyroid disease)
  • Hormonal Replacement Therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Center for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorSarcopeniaMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalMotor Activity

Condition Hierarchy (Ancestors)

BehaviorPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Daniel R Moore, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Hugo JW Fung, PhD

    University of Toronto

    STUDY DIRECTOR

Central Study Contacts

Daniel R Moore, PhD

CONTACT

4169464088dr.moore@utoronto.ca

Matthew J Lees, PhD

CONTACT

matthew.lees@utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Muscle Physiology

Study Record Dates

First Submitted

February 21, 2023

First Posted

April 12, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

CA(1)