PB125, Osteoarthritis, Pain, Mobility, and Energetics
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Muscle Weakness
- Osteoarthritis (Knee)
- Pain, Joint
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Primary comparisons will be between pre-test and post-test measures. We had initially planned control group comparisons as well, but the pandemic has cut this pilot study short of budget and time. Therefore, the primary comparisons will now be pre-test to post-test to maximize the number of participants enrolled to receive the experimental treatment.Masking: Double (Participant, Outcomes Assessor)Masking Description: Participants will not know if they are receiving PB125 or placebo. Participants will complete pain surveys. Team members making measurements of mobility and mitochondrial energetics will not know if participants or samples are PB125 or placebo.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 65 years
- Gender
- Both males and females
Description
Preventing or slowing age-related decline in musculoskeletal function is important for maintaining mobility and independence. In the US, osteoarthritis (OA) is the primary cause of disability in adults, with no medical or surgical therapeutic intervention known to restore the degenerated cartilage. ...
Preventing or slowing age-related decline in musculoskeletal function is important for maintaining mobility and independence. In the US, osteoarthritis (OA) is the primary cause of disability in adults, with no medical or surgical therapeutic intervention known to restore the degenerated cartilage. The loss of skeletal muscle mass and function with age, is also linked to increased risk of other diseases, risk of falls, and decreased quality of life. Therefore, OA and muscle loss together are primary contributors to age-related decreases in mobility and independence. Evidence suggests a decrease in muscle quality is associated with or precedes primary knee OA, suggesting that these two conditions may share a common cause. We will treat 50-65 year old people with mild or moderate OA in both knees, and reported loss of muscle strength, with a supplement already available for use in humans to reduce oxidative stress and inflammation. The supplement is called PB125. In this pilot clinical trial, we will measure the ability of muscle to make energy, measure mobility (walking and standing) and strength, and assess pain following PB125 or placebo treatment.
Tracking Information
- NCT #
- NCT04638387
- Collaborators
- Not Provided
- Investigators
- Not Provided
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