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Recruiting

NCT Number: NCT05926219

C-Protein in Fatigue and Aging

This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

Location status: Recruiting

Location contact

Damien M Callahan, Ph.D.

CONTACT

[email protected]

458-205-5343

Damien M Callahan, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

Age-related muscle atrophy and contractile dysfunction have been well described at the cellular level, but the molecular mechanisms that contribute to this dysfunction are poorly understood. Improved understanding of these mechanisms is critically important for the improvement of physical rehabilitation in older adults at risk for mobility impairment and physical disability. Our studies will pursue pre-clinical evidence that post translational modification of specific proteins in skeletal muscle lead to an "aging phenotype" in skeletal muscle that may unlock new strategies for improving physical function in older adults with physical frailty.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults between the ages 18-35 or 65-80 years
  • Healthy by self-report
  • Willing to participate in all aspects of the study design including muscle biopsy, unilateral exercise, and physical activity monitoring
  • Fluent in English (due to lack of translation services, it is not practical to conduct the study using a language other than English).

Exclusion criteria

  • Orthopaedic limitation (severe knee osteoarthritis, prior joint replacement, etc.).
  • Volunteer has dementia or related mental issues that potentially put the subject at risk as determined by prior diagnosis.
  • Volunteer has known untreated endocrine disease (hypo/hyper thyroidism, Addison's Disease or Cushing's syndrome, etc.)
  • Volunteer has untreated/poorly-controlled hypertension (stage 2, per American College of Cardiology [>140/90 mmHg]).
  • Volunteer has significant heart, liver, kidney or respiratory disease.
  • Volunteer has diabetes (insulin dependent or non-insulin dependent).
  • Volunteer has known coagulopathies.
  • Volunteer has taken anabolic steroids in the prior six months.
  • Volunteer has received treatment for cancer (other than effective Mohs Surgery for successful removal of basal cell or squamous cell carcinomas)
  • Unexpected weight loss >5kg is last 12 months
  • Volunteer is an active smoker or quit within the last year.
  • Volunteer has known current alcohol or drug use disorder (AUD; defined as binge drinking of >4 days in the last month. Binge drinking is >5 drinks for men and >4 drinks for women, per occasion). Or, if a volunteer reports drinking in excess of "low risk" per NIAAA (>7 drinks/week for men and >3 drinks/day for women and >14 drinks/week and >4 drinks/day).
  • Volunteer has a diagnosed neuromuscular disorder.
  • Volunteer has allergy to lidocaine.

Treatment and study plan

Fatiguing Exercise

Behavioral

Volunteers will perform knee extension exercise of the dominant limb while seated in a chair designed for exercise of the knee extensor muscle group. The chair will be equipped with a lever arm, aligned with the axis of rotation of the knee and fixed to the distal shank, 2 centimeters proximal to the ankle joint. The lever arm will be instrumented to provide resistance and measure velocity. The volunteers will perform 3-5 maximum voluntary contractions (MVC) to determine peak torque. Once established, volunteers will rest for 5 minutes before initiating the fatigue protocol, whereby they will perform repeated MVC of the dominant limb against resistance equal to or less than 50% of MVC until range of motion cannot be maintained. Because the goal of this exercise is to uniformly fatigue the quadriceps muscle group, this exercise will be performed continuously. It is expected to take between 1 and 3 minutes to achieve the desired level of fatigue.

Primary outcomes

  1. Phosphorylation of myosin binding protein c (MyBP-C)

    Time frame: One week after the participant undergoes the biopsies.

    Muscle tissue is immediately frozen after biopsy. Liquid chromatography and high resolution mass spectrometry will be used to do a full analysis of the phosphorylation sites on MyBP-C isolated from the biopsied muscle tissue.

Secondary outcomes

  1. Muscle fiber Force

    Time frame: Within three weeks of the intervention and biopsies.

    Ex vivo assessment of Force (mN) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.

  2. Muscle fiber Tension

    Time frame: Within three weeks of the intervention and biopsies.

    Ex vivo assessment of Tension (kPa) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.

  3. Muscle fiber Velocity

    Time frame: Within three weeks of the intervention and biopsies.

    Ex vivo assessment of Velocity (Lo/s) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.

  4. Muscle fiber Power

    Time frame: Within three weeks of the intervention and biopsies.

    Ex vivo assessment of Power (w/L) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.

Study contacts

Contact information is provided by the study sponsor or research team.

Damien M Callahan, Ph.D.

CONTACT

[email protected]

541-346-5040

Karen Wiedenfeld Needham, BS

CONTACT

[email protected]

541-346-7610

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
  • Oregon Health and Science University
  • Washington State University
  • Wu Tsai Human Performance Alliance

Registry information

Official study title

Skeletal Muscle Myosin Binding Protein C in Fatigue and Aging

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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