Artinia Clinical Trial Results on OxLDL Published in EJCN
This gold-standard study design was a 6-week, randomized, double-blind, placebo-controlled clinical trial evaluating the insoluble fiber chitin-glucan (derived from the Aspergillus niger mycelium), commercially available as ARTINIA.
12 Sep 2012 --- Stratum Nutrition, a Novus International Business focusing on nutrition through functional and specialty ingredients, has announced the publication of its clinical trial “Chitin-Glucan Fiber Effects on Oxidized Low-Density Lipoprotein: A Randomized Controlled Trial” in the European Journal of Clinical Nutrition (doi:10.1038/ejcn.2012.121).
This gold-standard study design was a 6-week, randomized, double-blind, placebo-controlled clinical trial evaluating the insoluble fiber chitin-glucan (derived from the Aspergillus niger mycelium), commercially available as Artinia. The primary objective of this study was to evaluate the efficacy of chitin-glucan (CG), alone and in combination with a potentially anti-inflammatory olive oil (OO) extract, for reducing oxidized low-density lipoprotein (OxLDL) in subjects with borderline to high LDL cholesterol (LDL-C) levels.
Evaluating 130 subjects free of diabetes mellitus with fasting LDL-C 3.37–4.92 mmol/l (130-189.9 mg/dl), participants were randomly assigned to receive CG (4.5 g/day), CG (1.5 g/day), CG (1.5 g/day) plus OO extract (135 mg/day), or matching placebo. The results showed that administration of 4.5 g/day CG for 6 weeks significantly reduced OxLDL compared with placebo. At the end of study, CG was associated with lower LDL-C levels relative to placebo, although this difference was statistically significant only for the CG 1.5 g/day group.
Elevated OxLDL has been linked to inflammation, and is associated with increased risk of atherosclerotic coronary heart disease, endothelial dysfunction, the metabolic syndrome, and worsening complications of diabetes mellitus. In conclusion, this 6-week study showed CG (4.5 g/day) reduces circulating OxLDL, an effect that might reduce the risk for atherosclerosis. According to Dr. Joseph L. Evans, Executive Manager, Pharmacology for Stratum Nutrition and Co-Investigator on this study, “…these results are very supportive of previous results obtained in animal models regarding the beneficial effects of chitin-glucan on cardiovascular health, and provide a strong rationale to pursue additional research with this unique fiber ingredient.”
A preliminary report of these findings was previously presented during the American Heart Association “Epidemiology and Prevention/Nutrition, Physical Activity and Metabolism 2012” Scientific Sessions in San Diego, California in March. Stratum Nutrition hopes to gain further recognition for this emerging biomarker – oxidized LDL (OxLDL) - with this reputable organization.
