Osteoarthritis, KneeNCT04638387
PB125, Osteoarthritis, Pain, Mobility, and Energetics
A study testing PB125 in people with Osteoarthritis, Knee and Muscle Weakness, run by Colorado State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee, Muscle Weakness, Pain, Joint
- What is being tested?
- PB125
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral knee osteoarthritis
Who cannot join
- smoking
- pregnant/breastfeeding
- BMI >30
- known liver, renal, heart disease, diabetes, autoimmune disease, cancer
- use of methotrexate, etanercept, infliximab, leflunomide, plaquenil
- recent serious illness
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523-1582
About this study
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
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.
Read the detailed 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. 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.
- Conditions
- Osteoarthritis, Knee, Muscle Weakness, Pain, Joint
- Being tested
- PB125, Placebo
- Medical subject headings
- Osteoarthritis, Knee, Muscle Weakness, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB125Dietary supplement
Nrf2 activator containing active ingredients carnosol, withaferin A, and luteolin.
PlaceboDietary supplement
Also called Flour
Placebo comparator to P125
| Study group | Role | What they receive |
|---|---|---|
| PB125 | Experimental | Twice daily oral administration of 1 capsule of PB125 (Pathways Bioscience). Treatment will last 12 weeks. Receives: Dietary Supplement: PB125 |
| Placebo | Placebo comparator | Twice daily oral administration of 1 capsule of rice flour placebo (Pathways Bioscience). Treatment will last 12 weeks. Because of pandemic restricting study time frame, enrollment will favor the experimental arm in this pilot study Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility-6 min self-paced walk
Change in Distance walked
Measured: Change from baseline at 12 weeks
Mobility-sit to stand
Change in Time for 5 sit to stand repetitions
Measured: Change from baseline at 12 weeks
Mobility-static balance
Yes/No ability to complete 30 sec trials with eyes open or closed on firm and foam surfaces
Measured: Change from baseline at 12 weeks
Mobility-6 min fast-paced walk
Change in Distance walked
Measured: Change from baseline at 12 weeks
Intermittent and Constant Knee Pain
Weekly change in Intermittent and Constant Pain Score (ICOAP) 11 question survey of pain on a 0-4 scale
Measured: Change weekly for 12 weeks
Energetics-Submaximal Oxygen Consumption
Change in oxygen (O2) flux in permeabilized muscle fibers at submaximal adenosine diphosphate (ADP) concentrations
Measured: Change from baseline at 12 weeks
Energetics-Maximal Oxygen Consumption
Change in O2 flux in permeabilized muscle fibers at maximal ADP concentrations
Measured: Change from baseline at 12 weeks
Secondary outcomes (4)
Energetics-hydrogen peroxide emission
Change in Hydrogen peroxide emission in permeabilized muscle fibers
Measured: Change from baseline at 12 weeks
Bone Mineral Density
Bone mineral density via dual x-ray absorptiometry (DEXA)
Measured: Change from baseline at 12 weeks
Knee Range of Motion
Change in active and passive bilateral knee range of motion
Measured: Change from baseline at 12 weeks
Leg extensor strength
Change in maximal force generated during knee extension
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start3 Nov 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: pandemic limited recruitment; funding ran out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karyn Hamilton, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638387
- Sponsor's protocol ID
- 19-9100H
- Status last verified
- Sep 2022
- First submitted
- 12 Nov 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04638387
- Acronym / sponsor ID
- 19-9100H
- Conditions
- Osteoarthritis, Knee, Muscle Weakness, Pain, Joint
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: pandemic limited recruitment; funding ran out
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PB125 | Experimental | Dietary Supplement: PB125Twice daily oral administration of 1 capsule of PB125 (Pathways Bioscience). Treatment will last 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwice daily oral administration of 1 capsule of rice flour placebo (Pathways Bioscience). Treatment will last 12 weeks. Because of pandemic restricting study time frame, enrollment will favor the experimental arm in this pilot study |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral knee osteoarthritis
Key exclusion criteria (17 listed)
- smoking
- pregnant/breastfeeding
- BMI >30
- known liver, renal, heart disease, diabetes, autoimmune disease, cancer
- use of methotrexate, etanercept, infliximab, leflunomide, plaquenil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PB125Nrf2 activator containing active ingredients carnosol, withaferin A, and luteolin. | Dietary supplement | PB125 |
| PlaceboAlso: FlourPlacebo comparator to P125 | Dietary supplement | Placebo |
Primary outcome
Mobility-6 min self-paced walk
Time frame: Change from baseline at 12 weeks
Change in Distance walked
Mobility-sit to stand
Time frame: Change from baseline at 12 weeks
Change in Time for 5 sit to stand repetitions
Mobility-static balance
Time frame: Change from baseline at 12 weeks
Yes/No ability to complete 30 sec trials with eyes open or closed on firm and foam surfaces
Mobility-6 min fast-paced walk
Time frame: Change from baseline at 12 weeks
Change in Distance walked
Intermittent and Constant Knee Pain
Time frame: Change weekly for 12 weeks
Weekly change in Intermittent and Constant Pain Score (ICOAP) 11 question survey of pain on a 0-4 scale
Energetics-Submaximal Oxygen Consumption
Time frame: Change from baseline at 12 weeks
Change in oxygen (O2) flux in permeabilized muscle fibers at submaximal adenosine diphosphate (ADP) concentrations
Energetics-Maximal Oxygen Consumption
Time frame: Change from baseline at 12 weeks
Change in O2 flux in permeabilized muscle fibers at maximal ADP concentrations
4 secondary outcomes
Energetics-hydrogen peroxide emission
Time frame: Change from baseline at 12 weeks
Bone Mineral Density
Time frame: Change from baseline at 12 weeks
Knee Range of Motion
Time frame: Change from baseline at 12 weeks
Leg extensor strength
Time frame: Change from baseline at 12 weeks
Results and safety
The study was stopped early (reason given: pandemic limited recruitment; funding ran out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PB125 in people with Osteoarthritis, Knee and Muscle Weakness, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: pandemic limited recruitment; funding ran out). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility-6 min self-paced walk (time frame: Change from baseline at 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.