PLT Announces New Clinical Study on AprèsFlex 5-Day Joint Support Ingredient that Confirms Fast-Acting Efficacy from 100 mg/Day Dose

Patented Boswellia serrata complex improves joint comfort and enhances and improves joint function

MORRISTOWN, N.J., July 20, 2022 /PRNewswire/ -- PLT Health Solutions, Inc announced the publication of a clinical study on its Boswellia serrata-based AprèsFlex^® 5-Day Joint Support ingredient that provides further evidence of its ability to support joint health and function with statistically significant improvements in pain scores and biomarkers starting at only five days from initial consumption. Published in The Journal of the American Nutrition Association, the study is entitled "Efficacy and Safety of Aflapin^®, a Novel Boswellia Serrata Extract, in the Treatment of Osteoarthritis of the Knee: A Short-Term 30-Day Randomized, Double-Blind, Placebo-Controlled Clinical Study"[1]  and authored by Vasu Karlapudi, Krishna Bhagavan Sunkara, Purna Rajeswari Konda, Kadainti V. Sarma, and Meher Prasanna Rokkam. Aflapin is an alternative trade name for the AprèsFlex ingredient that is marketed globally by PLT Health Solutions. This is the third double-blind placebo controlled study conducted with AprèsFlex and the second study to confirm statistically significant improvements in joint comfort beginning at five days from a remarkably low dose – 100 mg/day. The ingredient is produced by PLT innovation partner Laila Nutraceuticals (Krishna, Andhra Pradesh, India).

According to Seth Flowerman, President & CEO of PLT Health Solutions, this new study further builds on the strong existing data supporting AprèsFlex as a powerful and fast-acting, low-dose joint health ingredient. "When it comes to mobility, there can be a disconnect between what consumers want and what existing solutions deliver. Too often, natural joint and muscle health solutions require large doses that take weeks or even months to show improvements - and the science backing these ingredients doesn't support what consumers are looking for. That is one of the reasons we continually work to understand things like mechanism of action and to develop quality science that can support strong messaging," he said. "At PLT, we are working to deliver Mobility Solutions, and to make these solutions available for people of all ages and walks of life," he added.

Patented formulation combats inflammation

AprèsFlex is a patented, synergistic combination of two proprietary extracts derived from Boswellia serrata gum resin, launched in 2013. The oral bioavailability of acetyl-11-keto-beta-boswellic acid (AKBA) from AprèsFlex is significantly higher than that of other commercially available Boswellia extracts, which allows for a lower daily dose, with enhanced efficacy. In joint health products, AprèsFlex is used often as a standalone ingredient or in conjunction with other ingredients to power some of the best-known joint health consumer brands in the world. It has been the subject of seven pre-clinical studies and three published human clinical trials.

Third study provides confirmation of fast-acting relief and sheds light on key biomarkers

In the newest clinical study, Karlapudi and colleagues examined the efficacy of AprèsFlex in the management of joint comfort and function in a randomized, double-blind, placebo clinical trial. Sixty-seven subjects received either 100 mg/day of AprèsFlex or a matching placebo for thirty days.

Measurements included:

• Visual Analog Score (VAS)
• The Lequesne algofunctional index (LFI)
• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
• Serum biomarkers (MMP3, TNF, hsCRP, COMP, CPII and C2C)

Measurements were done on Days 0, 5 and 30.

The study showed that AprèsFlex provided significant improvement (p<0.05) in all pain and physical function scores at five days compared to placebo. Post-trial, VAS, LFI, WOMAC pain, WOMAC stiffness, WOMAC function, and total WOMAC scores decreased in the AprèsFlex group by 45%, 40.9%, 44.4%, 66.3%, 44.4%, and 48%, respectively.

Beyond joint comfort and function improvements, AprèsFlex was also shown to offer statistically significant impact on biological markers associated with joint health and inflammation metabolism, including TNF-alpha, C-Reactive Protein (CRP), and Interleukin-6 (IL-6). It was also shown to significantly inhibit matrix metalloproteinase (MMP-3), an enzyme that breaks down cartilage, collagen, and connective tissue.

Previous studies with AprèsFlex showed 56% reduction in pain scores at 30 days. A similar study with AprèsFlex showed a 69% reduction in pain scores at 90 days.

According to Dr. Jeremy Appleton,  Director of Medical and Scientific Affairs for PLT, this new study confirms previous results with AprèsFlex and should give innovators of joint health and mobility products confidence in the fast-acting messaging supported by the science. "We now have three double-blind placebo-controlled clinical trials that validate the efficacy of AprèsFlex, and two demonstrating improvements as early as five days, at a low dose. These outcomes support our customers' "fast-acting" claims for their products containing AprèsFlex. At PLT Health Solutions, we are continually evaluating our existing science and conducting new research that enables our customers to offer strong messaging while building trust with their own customers," he said.

In addition to this new stand-alone study on AprèsFlex, ingredient company Bioiberica announced an open-label study in June 2022  that combined AprèsFlex with its Collavant^® n2 type-II collagen complex. That study further demonstrated the five-day efficacy of AprèsFlex at 100 mg/day, when used as part of a combination formula Dr. Appleton commented, "The Karlapudi study, along with the new study announced by Bioiberica, continues to strengthen the evidence that AprèsFlex can rapidly improve people's lives."

To learn more about AprèsFlex, contact the company or visit the PLT website at www.plthealth.com/apresflex.

[1] Karlapudi V, Sunkara KB, Konda PR, Sarma KV, Rokkam MP. Efficacy and Safety of Aflapin^®, a Novel Boswellia Serrata Extract, in the Treatment of Osteoarthritis of the Knee: A Short-Term 30-Day Randomized, Double-Blind, Placebo-Controlled Clinical Study [published online ahead of print, 2022 Feb 15]. J Am Nutr Assoc. 2022;1-10. doi:10.1080/07315724.2021.2014370

SOURCE PLT Health Solutions