PLT Health Solutions received an updated license from the Non-Prescription Health Products Directorate (NNHPD) of Health Canada to market its ingredient, AprèsFlex 5-Day Joint Support.
 
The update reflects additional health claims approved for marketing following a fourth clinical study on the Boswellia serrata gum resin extract.
 
In joint health products, AprèsFlex is used as a standalone ingredient or in combination with other ingredients.
 
The granting of the latest Natural Health Products license is significant for what it says about the quality of the science that supports the ingredient, according to Seth Flowerman, president and CEO of PLT Health.
 
“With four gold-standard human clinical trials and counting, we are proud that AprèsFlex is one of the best-substantiated joint health ingredients on the market today, powering some of the leading joint health consumer brands around the world,” Flowerman said. “The combination of fast-acting experiential improvements in joint comfort with demonstrated long-term efficacy, and now with the newly-demonstrated claims on cartilage health, both preservation and protection, offers the industry never-before available messaging opportunities for consumer products benefitting people of all ages, and all in a single, low daily dose of 100 mg. Health Canada is well-known for their rigorous scientific review process and the breadth and quality of claims permitted speaks to the high quality of science on this ingredient.”
 
Study Details
 
In the randomized, double-blind, placebo-controlled clinical trial, 80 normal-to-overweight women and men between the ages of 40 and 75 either received 100 mg per day of AprèsFlex or a matching placebo for six months. Study endpoints included joint comfort, through tests like the WOMAC, VAS, and Lequesne Functional Index; functional capacity testing, through the six-minute walk and stair climb tests; and MRI evaluation of the knee joints to assess joint space narrowing, cartilage thickness, and cartilage volume. The researchers also assessed changes in biomarkers related to cartilage breakdown and inflammation.
 
Those in the AprèsFlex group steadily reported improvements in joint discomfort, with a 70% reduction in pain scores by the end of the study. Those same subjects experienced 25% less stiffness in the first month, and a 72% reduction in stiffness at six months. AprèsFlex was also associated with a 71% improvement in physical function at six months.
 
MRI results showed decreases in the thickness and volume of femoral, patellar, lateral tibial, and medial tibial cartilage over time, while cartilage thickness and volume was maintained or slightly improved in those taking AprèsFlex at 180 days.
 
The list of claims approved by Health Canada for AprèsFlex includes:

• Provides long-term joint health benefits/support/pain relief in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps support improvements to joint comfort, stiffness and function over 6 months in persons with mild to moderate osteoarthritis of the knee.
• Helps to maintain joint space in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to maintain cartilage in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to maintain cartilage thickness/volume in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to protect (knee) cartilage in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to reduce cartilage breakdown in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to reduce key biomarkers of cartilage breakdown in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to improve joint function in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to improve/increase mobility when walking and stair-climbing in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to support joint function capacity when walking and stair-climbing in subjects suffering from mild to moderate osteoarthritis of the knee.
• Helps to protect against the deterioration of cartilage in persons with mild to moderate osteoarthritis of the knee.
• A factor in maintaining healthy cartilage and/or joint health in persons with mild to moderate osteoarthritis of the knee.
• Helps protect against the deterioration of cartilage in persons with mild to moderate osteoarthritis of the knee and relieve joint pain associated with mild to moderate osteoarthritis of the knee.
• Helps to improve/increase mobility in those suffering from mild to moderate osteoarthritis of the knee.
• Helps reduce mild to moderate osteoarthritic knee joint pain when walking and climbing stairs.