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Clinical Trials/NCT04799171
NCT04799171
Completed
Not Applicable

Aging and the Mitochondrial Response to Exercise Training, Measured by Noninvasive 31P Magnetic Resonance Spectroscopy (MoTrMito)

Pennington Biomedical Research Center1 site in 1 country352 target enrollmentAugust 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
Pennington Biomedical Research Center
Enrollment
352
Locations
1
Primary Endpoint
Post-training 31P MRS measurement - Phosphocreatine recovery rate
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The goal of the study is to determine whether aerobic or resistant exercise can improve in vivo mitochondrial capacity of skeletal muscle cells similarly in healthy younger, middle aged and older adults. This confers long-term changes in this tissue which in-turn contribute to improved metabolic health and functional capacity through epigenetic regulation of novel exercise response genes.

Detailed Description

The goal of the study is to understand the biological pathways and molecules driving the exercise response variation of the muscle mitochondria in vivo to elucidate the underlying mechanisms for the health benefits of exercise training in young, middle aged and older adults. This knowledge will improve investigators understanding of biological basis for targeted "precision medicine" exercise and non-exercise interventions to improve age related conditions. The mitochondrial capacity measurement via non-invasive 31P magnetic resonance spectroscopy (31-MRS) will provide a tangible link between the two primary foci of the parent MoTrPAC study: molecular drivers of exercise response and key phenotypic health outcomes.

Registry
clinicaltrials.gov
Start Date
August 2, 2021
End Date
May 12, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Owen Carmichael

Director Biomedical Imaging Center

Pennington Biomedical Research Center

Eligibility Criteria

Inclusion Criteria

  • ADULT PARTICIPANT INCLUSION CRITERIA - YOUNG PARTICIPANTS
  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged 18 - 39 y
  • Body Mass Index (BMI) \>19 to \<35 kg/m2
  • ADULT PARTICIPANT INCLUSION CRITERIA - MIDDLE AGE PARTICIPANTS
  • Willingness to provide informed consent to participate in the MoTrMito Study
  • Must be able to read and speak English well enough to provide informed consent and understand instructions
  • Aged 40 - 59 y
  • Body Mass Index (BMI) \>19 to \<35 kg/m2

Exclusion Criteria

  • ADULT PARTICIPANT EXCLUSION CRITERIA
  • Exclusion criteria are confirmed by either self-report (i.e., medical and medication histories reviewed by a clinician), screening tests performed by the MoTrMito study team at each clinical site, and/or clinician judgement as specified for each criterion.
  • Diabetes (self-report and screening tests)
  • Treatment with any hypoglycemic agents (self-report) or A1c \>6.4 (screening test; may reassess once if 6.5-6.7)
  • Fasting glucose \>125 (screening test; may reassess once)
  • Use of hypoglycemic drugs (e.g., metformin) for non-diabetic reasons (self-report)
  • Abnormal bleeding or coagulopathy (self-report)
  • History of a bleeding disorder or clotting abnormality
  • Thyroid disease (screening test)
  • Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory

Outcomes

Primary Outcomes

Post-training 31P MRS measurement - Phosphocreatine recovery rate

Time Frame: After week 12 visit - after all muscle biopsies and exercise training.

The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.

Pre-training 31P MRS measurement - Phosphocreatine recovery rate

Time Frame: Baseline visit - before any muscle biopsies or exercise training.

The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.

Study Sites (1)

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