Back to resultsC-Protein in Fatigue and Aging
Primary Purpose
Aging, Muscle Atrophy or Weakness, Sarcopenia in Elderly
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fatiguing Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Aging focused on measuring muscle, aging, elderly, myosin, protein, sarcomere, exercise, function, atrophy, contractile, strength, balance, mobility, MyBP-C, fiber, biopsy, skeletal muscle, fatigue
Eligibility Criteria
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.
Sites / Locations
- University of OregonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fatigue
Arm Description
Volunteers will perform one-legged knee extension exercise until fatigue while seated on an ergometer. Volunteers will then undergo bilateral skeletal muscle biopsies of the vastus lateralis muscle in their thigh.
Outcomes
Primary Outcome Measures
Phosphorylation of myosin binding protein c (MyBP-C)
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 Outcome Measures
Muscle fiber Force
Ex vivo assessment of Force (mN) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Muscle fiber Tension
Ex vivo assessment of Tension (kPa) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Muscle fiber Velocity
Ex vivo assessment of Velocity (Lo/s) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Muscle fiber Power
Ex vivo assessment of Power (w/L) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Full Information
NCT ID
NCT05926219
First Posted
May 31, 2023
Last Updated
October 6, 2023
Sponsor
University of Oregon
Collaborators
Wu Tsai Human Performance Alliance, National Institutes of Health (NIH), Oregon Health and Science University, Washington State University, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05926219
Brief Title
C-Protein in Fatigue and Aging
Official Title
Skeletal Muscle Myosin Binding Protein C in Fatigue and Aging
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
Collaborators
Wu Tsai Human Performance Alliance, National Institutes of Health (NIH), Oregon Health and Science University, Washington State University, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Muscle Atrophy or Weakness, Sarcopenia in Elderly, Sarcopenia
Keywords
muscle, aging, elderly, myosin, protein, sarcomere, exercise, function, atrophy, contractile, strength, balance, mobility, MyBP-C, fiber, biopsy, skeletal muscle, fatigue
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fatigue
Arm Type
Experimental
Arm Description
Volunteers will perform one-legged knee extension exercise until fatigue while seated on an ergometer. Volunteers will then undergo bilateral skeletal muscle biopsies of the vastus lateralis muscle in their thigh.
Intervention Type
Behavioral
Intervention Name(s)
Fatiguing Exercise
Intervention Description
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 Outcome Measure Information:
Title
Phosphorylation of myosin binding protein c (MyBP-C)
Description
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.
Time Frame
One week after the participant undergoes the biopsies.
Secondary Outcome Measure Information:
Title
Muscle fiber Force
Description
Ex vivo assessment of Force (mN) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Time Frame
Within three weeks of the intervention and biopsies.
Title
Muscle fiber Tension
Description
Ex vivo assessment of Tension (kPa) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Time Frame
Within three weeks of the intervention and biopsies.
Title
Muscle fiber Velocity
Description
Ex vivo assessment of Velocity (Lo/s) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Time Frame
Within three weeks of the intervention and biopsies.
Title
Muscle fiber Power
Description
Ex vivo assessment of Power (w/L) will be performed on muscle fibers and bundles isolated from fatigued and non-fatigued muscle biopsies.
Time Frame
Within three weeks of the intervention and biopsies.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien M Callahan, Ph.D.
Phone
541-346-5040
Email
damienc@uoregon.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Wiedenfeld Needham, BS
Phone
541-346-7610
Email
needham@uoregon.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien M Callahan, Ph.D.
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien M Callahan, Ph.D.
Phone
458-205-5343
Email
damienc@uoregon.edu
First Name & Middle Initial & Last Name & Degree
Damien M Callahan, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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C-Protein in Fatigue and Aging
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