The Natural and Non-Prescription Health Products Directorate of Health Canada has given PLT a license for AlvioLife
PLT Health Solutions has received a license from the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada to market its ingredient AlvioLife to support respiratory health in Canada.
AlvioLife is a proprietary composition of extracts of Boswellia serrata gum resin [standardised to 30% 3-O-acetyl-11-keto-ß-boswellic acid (AKBA)] and Aegle marmelos dried fruit, designed to support a respiratory health. Published clinical work has shown that it can help improve overall respiratory health, maintain clear airways, help against environmental exposure and soothe respiratory tissues.
In Canada, the approved claims include:
According to Dr Barbara Davis, Head of Clinical and Regulatory Sciences for PLT Health Solutions, the granting of an NHP license by Health Canada is a significant milestone for AlvioLife, both because it opens up the Canadian market for this unique ingredient and for what it says about the science that supports the AlvioLife.
"Respiratory health is at the top of everyone's minds these days. AlvioLife is an interesting ingredient both as a standalone but also as a compliment to immune support ingredients," Davis said. "The anti-inflammatory effects, particularly 5-lipoxygenase (5-LOX) inhibition by AKBA and quince fruit, are responsible for its effectiveness in supporting respiratory health. Accumulating and significant evidence suggests that 5‐LOX has profound influence on the onset and progression of airway inflammation."
A 56-day, randomised, double-blind placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of 200 mg/day AlvioLife in participants with respiratory issues. Statistically significant improvement was observed for several parameters of respiratory health in study participants taking AlvioLife compared to those receiving placebo.
Response to environmental stimuli and breathing scores were significantly better in the AlvioLife group compared to the placebo group. Peak Expiratory Flow (L/min) was significantly improved on day 56 in the AlvioLife group compared to the placebo (p<0.05) and Expiratory Volume 1 (FEV1) was improved on day 56 in AlvioLife group, but not in the placebo group.
Quality of life issues were also examined. Both activity limitation and emotional function scores were significantly improved on day 14, and further improved on days 28 and 56, compared to the placebo group.