PB125, Osteoarthritis, Pain, Mobility, and Energetics

NCT ID: NCT04638387

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2021-09-01

Brief 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. 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.

Conditions

Osteoarthritis, Knee; Muscle Weakness; Pain, Joint

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PB125

Twice daily oral administration of 1 capsule of PB125 (Pathways Bioscience). Treatment will last 12 weeks.

Group Type: EXPERIMENTAL

PB125

Intervention Type: DIETARY_SUPPLEMENT

Nrf2 activator containing active ingredients carnosol, withaferin A, and luteolin.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo comparator to P125

Interventions

PB125

Nrf2 activator containing active ingredients carnosol, withaferin A, and luteolin.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo comparator to P125

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Flour

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Karyn Hamilton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Colorado State University

Fort Collins, Colorado, United States

Countries

United States

Related Links

https://www.research.colostate.edu/wp-content/uploads/2020/07/Knee-Osteoarthritis-Study-in-Health-and-Exercise-Science.pdf

Study Flyer on Colorado State University Center for Healthy Aging Website

Other Identifiers

19-9100H

Identifier Type: -

Identifier Source: org_study_id