PB125, Osteoarthritis, Pain, Mobility, and Energetics

NCT04638387 | Terminated

• 1 other identifier: 19-9100H
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Muscle Weakness; Pain, Joint

Outcome Measures

Primary Outcomes (7)

• Mobility-6 min self-paced walk

  Change in Distance walked

  Change from baseline at 12 weeks

• Mobility-sit to stand

  Change in Time for 5 sit to stand repetitions

  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

  Change from baseline at 12 weeks

• Mobility-6 min fast-paced walk

  Change in Distance walked

  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

  Change weekly for 12 weeks

• 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

• Energetics-Maximal Oxygen Consumption

  Change in O2 flux in permeabilized muscle fibers at maximal ADP concentrations

  Change from baseline at 12 weeks

Secondary Outcomes (4)

• Energetics-hydrogen peroxide emission

  Change from baseline at 12 weeks

• Bone Mineral Density

  Change from baseline at 12 weeks

• Knee Range of Motion

  Change from baseline at 12 weeks

• Leg extensor strength

  Change from baseline at 12 weeks

Study Arms (2)

PB125

EXPERIMENTAL

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

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

Dietary Supplement: Placebo

Interventions

PB125 DIETARY_SUPPLEMENT

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

PB125

Placebo DIETARY_SUPPLEMENT

Placebo comparator to P125

Also known as: Flour

Placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral knee osteoarthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523-1582, United States

Location

Related Links

• Study Flyer on Colorado State University Center for Healthy Aging Website

MeSH Terms

Conditions

Osteoarthritis, Knee; Muscle Weakness; Arthralgia

Interventions

Flour

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 20, 2020
• Study Start: November 3, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

US (1)