GlycaNova, and its collaborators, have carried out a substantial number of mechanistic, preclinical and clinical studies of Lentinex in Norway and the United States.
Importantly, GlycaNova showed that its proprietary production process was able to isolate undenatured beta-glucan from shiitake mushroom mycelia (Kristiansen, B. (2009) Immune Modulating Compounds from Fungi US 7,514,085 April 6, 2009.) Subsequent research has shown that this undenatured beta-glucan, in its triple helix tertiary form, is far superior to any denatured beta-glucan in its ability to enhance the immune system.
Further details are included in a research paper on the safety and efficacy of Lentinex in a preclinical setting which was published in December 2021 (Ronald J Amen and Bjorn Kristiansen. Safety and Efficacy Studies on Administration of Undenatured Beta Glucan in Experimental Animals. Nutrition and Food Toxicology 4.2 (2021): 24-29.) The paper confirms the safety of Lentinex in rat and mouse models and also details the effects of Lentinex on the murine immune system, demonstrating a doubling of B-cells.
This preclinical work has been followed by a series of clinical studies examining safety and efficacy and looking at a number of different groups of people, including healthy subjects, fatigued individuals and those with low levels of B-cells. These studies are summarised in a paper published in February 2021 (Kristiansen, B. and Amen, R.J. (2022) Safety and Efficacy of a Proprietary Undenatured Beta-Glucan on Different Human Populations. Advances in Biological Chemistry, 12, 16-28. https://doi.org/10.4236/abc.2022.121002). Three of the clinical studies focused on quality of life of the subjects and the results showed an ability of Lentinex to improve quality of life, manifested by increased energy/decreased fatigue, decreased stress and decreased depression. The results suggest that Lentinex is optimising the human immune system through B-cell production.
GlycaNova has conducted an extensive amount of ex vivo and other work in comparing denatured beta-glucans with Lentinex, its own undenatured beta-glucan, particularly looking at the specific components of the immune system (including cytokines, chemokines, complement and growth factors) and also at the absorption of Lentinex compared with denatured, commercially available products. These studies have shown that the triple helix tertiary structure of Lentinex enables absorption and that the immunostimulatory effects are significantly greater than those seen in denatured beta-glucans.