Morristown, NJ 26 September 2023 – PLT Health Solutions, Inc. announced that it has received an expanded 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 and Aegle marmelos dried fruit, designed to support respiratory health. A second clinical study conducted in 2022 confirmed efficacy in supporting lung function, aerobic exercise capacity and overall well-being.

In Canada, the complete list of approved claims now includes:

• AlvioLife helps to support lower respiratory tract health
• AlvioLife helps to support lower respiratory tract health that includes the bronchial tubes and the lungs’ health
• Supports lower respiratory system function
• Clinically shown to support health lower respiratory system function

According to Seth Flowerman, President and CEO of PLT Health Solutions, the granting of an NHP license for AlvioLife by Health Canada is significant both because it opens the Canadian market for this unique ingredient and for what it says about the science that supports the AlvioLife. “Respiratory health is top of mind these days, particularly with the compromised air quality we have seen throughout North America as a result of rampant wildfires,” he said. “The impressive anti-inflammatory effects of AlvioLife are responsible for its effectiveness in supporting respiratory health. Health Canada has a high bar for respiratory and clinically supported health claims, and we are proud of the quality of science supporting this innovative and impactful ingredient,” he added.

New Clinical Study Confirms and Expands Respiratory Health Benefit Messaging

In 2022, PLT announced the completion of the second double-blind placebo-controlled clinical study on AlvioLife and respiratory health. In this six-week RCT, healthy subjects who reported air pollution sensitivity took either 200 mg/day of AlvioLife or a matching placebo. Subjects taking AlvioLife experienced statistically significant improvements from baseline and compared to placebo for lung function, lung capacity and aerobic exercise capacity. In addition to these results, the study showed reductions in reported upper respiratory tract symptoms (Wisconsin Upper Respiratory Symptom Scale)and improved psychological well-being. Positive changes in immune (CD4+) and inflammatory (IL-8) biomarkers were also shown. This is the second clinical study of AlvioLife to demonstrate support for healthy respiratory activity and perceived well-being. The research was presented at the 2023 American Society of Nutrition meeting in Boston in July. The abstract was published in the peer-reviewed journal Current Developments in Nutrition in August 2023.[1]
In 2023, AlvioLife was awarded the Ingredient of the Year Award from Nutraingredients USA in the Healthy Aging Category – based on these new clinical study results.

According to Jennifer Murphy, Director of Innovation & Clinical Development for PLT, the new study confirms previous results with AlvioLife but also points to broader benefits. “This new study – conducted in healthy subjects – brings the unique potential of AlvioLife into focus. The new clinical study points to the importance of respiratory health in all phases of our lives. Once again, we demonstrated improved lung function, but we can now see how this also translates into improvements in lung capacity, aerobic exercise capacity and a reduction in upper respiratory tract symptoms. The measurements of the well-being index suggest that people are indeed happier when they breathe easier,” she said. “For all these reasons, we are seeing interest in AlvioLife as a complementary ingredient in immune health and healthy aging categories in addition to the respiratory health space,” she added.

Learn more about these studies here.

Morristown, NJ 28 June 2022 – PLT Health Solutions, Inc announced a new clinical study conducted with its AlvioLife® ingredient that provides further evidence in support of respiratory and immune health, as well as perceived immune function and well-being. In a 2021 six-week RCT, healthy subjects who reported air pollution sensitivity took either 200 mg/day of AlvioLife  or a matching placebo. Subjects taking AlvioLife experienced statistically significant improvements from baseline and compared to placebo for lung function, lung capacity and aerobic exercise capacity. In addition to these results, the study showed reductions in reported upper respiratory tract symptoms (Wisconsin Upper Respiratory Symptom Scale) and improved psychological well-being. Positive changes in immune (CD4+) and inflammatory (IL-8) biomarkers were also shown. This is the second clinical study of AlvioLife to demonstrate support for healthy respiratory activity and perceived well-being. The ingredient is manufactured by PLT innovation partner Laila Nutraceuticals.

According to Seth Flowerman, President & CEO of PLT Health Solutions, this new study shows how AlvioLife provides benefits that are front-of-mind for today’s consumers. “It’s easy to forget how many aspects of our lives are dependent on respiratory health – from overall health to emotional well-being to physical performance. And factors like environmental pollution can challenge optimal respiratory health,” he said. “AlvioLife can function as a standalone ingredient to support respiratory function for people who have respiratory sensitivities or live in higher pollution areas, as well as a component in immune health formulations – since the issue of respiratory health is so vital to the immune health equation. For companies looking to differentiate and enhance their immune health formulations, AlvioLife offers some unique benefits,” he added.

Patented formulation combats inflammation

AlvioLife is a patented composition of Boswellia serrata resin extract standardized to 30% 3-O-acetyl-11-keto-ß-boswellic acid (AKBA) and Bengal quince fruit extracts (Aegle marmelos). This combination of natural botanical extracts works via mechanisms that help balance the inflammatory response. It is a synergistic blend shown to possess stronger 5-lipoxygenase (5-LOX) inhibition activity than either of its constituent extracts alone. The 5-lipoxygenase enzyme has been shown in the literature to have significant influence on the onset and progression of airway inflammation. AlvioLife is actively sold in formulations to help maintain clear airways, soothe respiratory function and manage environmental irritants. It works well in a broad range of consumer formulations at a fast-acting, low-dose of 200 mg/day.

Second study provides confirmation and shows additional benefits

In an earlier double-blind study involving subjects with bronchial asthma[1], thirty-six subjects took AlvioLife (200 mg/d) or a matching placebo for 56 days. AlvioLife conferred significant improvements in the clinical parameters; the emotional function (p = .0305) and asthma symptoms scores (p = .0002) were improved even at 14 days, compared with the placebo. Further, 56 days supplementation of AlvioLife resulted in significant increase in serum IFN‐γ (p = .0014) and reduction in IL‐4 (p = .0497), compared with placebo.

In this second double-blind trial, which is currently in pre-publication, healthy subjects with self-reported sensitivity to pollution took either 200 mg/d of AlvioLife or a matching placebo for six weeks. AlvioLife was found to improve lung function (FEV1) by up to 16%; lung capacity (FVC) by up to 30%; aerobic exercise capacity by up to 7% (6-minute Walk test); to reduce upper respiratory tract symptoms (WURSS-21) by up to ~40%; improved perceived immune status (ISQ) in as early as three weeks; improved psychological well-being (PGWBI) by up to 18%; and improved the percentage of CD4+ T Helper Cells. In both studies, AlvioLife was found to be safe and well-tolerated.

According to Jennifer Murphy, Director of Innovation & Clinical Development for PLT, this new study confirms previous results with AlvioLife but also points to broader benefits. “This new study – conducted on healthy subjects – brings the unique potential of AlvioLife into focus. The new clinical study points to the importance of respiratory health in all phases of our lives. Once again, we demonstrated improved lung function, but we can now see how this also translates into improvements in lung capacity, aerobic exercise capacity and a reduction in upper respiratory tract symptoms. The measurements of the well-being index suggest that people are indeed happier when they breathe easier,” she said. “For all these reasons, we are seeing interest in AlvioLife as a complementary ingredient in the fast-growing immune health category,” she added.

To learn more about these studies, contact the company or visit the PLT website at www.plthealth.com/alviolife.

 
[1] Yugandhar P, Rao KM, Sengupta K. A novel herbal composition containing extracts of Boswellia serrata gum resin and Aegle marmelos fruit alleviates symptoms of asthma in a placebo controlled double-blind clinical study. Phytother Res. 2018;32(1):140-150. doi:10.1002/ptr.5963