Osteoarthritis, Knee Clinical Trial
Official title:
Nuclear Factor Erythroid 2-Related Factor 2 (Nrf2) Activation, Mobility, and Energetics: A Pilot and Feasibility Clinical Trial of PB125 Treatment for Improving Musculoskeletal and Pain Outcomes in Osteoarthritis
Verified date | September 2022 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nuclear factor erythroid 2-related factor 2 (Nrf2) is an important regulator in the body. It controls how well cells protect themselves against stress. PB125 (Pathways Bioscience) is a plant based activator of this important regulator Nrf2. PB125 is made up of three plant extracts (rosemary, ashwagandha, and Sophora japonica) so that it contains these things; 1. Carnosol, 2. Withaferin A, and 3. Luteolin. Carnosol comes from rosemary leaves. Rosemary is a spice often used in Italian foods and grown in many herb gardens all around Fort Collins. Withaferin A comes from the medicinal plant Withania somnifera, also called ashwagandha. Ashwaganda is commonly known as "Indian Winter cherry" or "Indian Ginseng" and it is one of the most important herbs of Ayurveda (the traditional system of medicine in India) used for millennia. Finally, luteolin is found widely in plants including those present in the diet (peppers, onions, celery, herbs/spices). Some people purchase these herbs commercially, and take them on their own for a variety of purposes. Typically, when you buy them, they will be in much higher doses than they are in PB125. What makes PB125 different is that very low doses of each of the 3 components work together-synergistically-to activate Nrf2 and increase the ability of cells to respond to stress. It is unknown if there are any benefits to taking PB125 and the risks are currently unknown. The purpose of this study is to examine changes in muscle, in joint pain, in mobility (standing and walking) and in leg strength that occur after consuming PB125 every day for 3 months. We want to make these measurements in people who have been diagnosed with mild to moderate osteoarthritis-a degenerative joint disease-in their knees.
Status | Terminated |
Enrollment | 4 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 65 Years |
Eligibility | Inclusion Criteria: - bilateral knee osteoarthritis Exclusion Criteria: - smoking - pregnant/breastfeeding - BMI >30 - known liver, renal, heart disease, diabetes, autoimmune disease, cancer - use of methotrexate, etanercept, infliximab, leflunomide, plaquenil - recent serious illness - intraarticular stem cell injection - intraarticular steroid or hyaluronic acid injection within 4 months - current enrollment in another trial of investigational drugs - known hypersensitivity to ashwagandha, luteolin, rosemary, or rice flour - use of anticoagulants or known bleeding disorder - unwillingness to comply with protocol - plans for knee replacement in the next 3 years - unable to complete mobility testing without ambulatory aid - unable to climb 1-2 flights or stairs without stopping/shortness of breath/discomfort - blood product transfusion within 30 days - unable to provide legal consent |
Country | Name | City | State |
---|---|---|---|
United States | Colorado State University | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mobility-6 min self-paced walk | Change in Distance walked | Change from baseline at 12 weeks | |
Primary | Mobility-sit to stand | Change in Time for 5 sit to stand repetitions | Change from baseline at 12 weeks | |
Primary | Mobility-static balance | Yes/No ability to complete 30 sec trials with eyes open or closed on firm and foam surfaces | Change from baseline at 12 weeks | |
Primary | Mobility-6 min fast-paced walk | Change in Distance walked | Change from baseline at 12 weeks | |
Primary | Intermittent and Constant Knee Pain | Weekly change in Intermittent and Constant Pain Score (ICOAP) 11 question survey of pain on a 0-4 scale | Change weekly for 12 weeks | |
Primary | Energetics-Submaximal Oxygen Consumption | Change in oxygen (O2) flux in permeabilized muscle fibers at submaximal adenosine diphosphate (ADP) concentrations | Change from baseline at 12 weeks | |
Primary | Energetics-Maximal Oxygen Consumption | Change in O2 flux in permeabilized muscle fibers at maximal ADP concentrations | Change from baseline at 12 weeks | |
Secondary | Energetics-hydrogen peroxide emission | Change in Hydrogen peroxide emission in permeabilized muscle fibers | Change from baseline at 12 weeks | |
Secondary | Bone Mineral Density | Bone mineral density via dual x-ray absorptiometry (DEXA) | Change from baseline at 12 weeks | |
Secondary | Knee Range of Motion | Change in active and passive bilateral knee range of motion | Change from baseline at 12 weeks | |
Secondary | Leg extensor strength | Change in maximal force generated during knee extension | Change from baseline at 12 weeks |
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