Other Human Clinical Trials Abstracts
Two different human clinical trials are highlighted in this section.
1. Jensen, G. S., et al. A double-blind placebo-controlled, randomized pilot study: consumption of a high-metabolite immunogen from yeast culture has beneficial effects on erythrocyte health and mucosal immune protection in healthy subjects. Open Nutr J 2008, 2, 68-75. [Online reference: https://opennutritionjournal.com/VOLUME/2/PAGE/68/ABSTRACT/]
This double-blind, randomized, placebo-controlled pilot study was designed to evaluate effects of consumption of an antioxidant-rich, yeast culture-based high-metabolite immunogen EpiCor. Twenty-five healthy participants consumed 0.5 gram EpiCor or placebo daily for 5 weeks. The hematocrit increased significantly in the EpiCor group (p<0.04). A mild increase in saliva sIgA upon EpiCor consumption (p=0.16) prompted a subsequent 8-week open-label study involving 22 people showing significant increase in sIgA (p<0.05). EpiCor consumption led to a mild increase in serum IL-10 (p<0.2); no other differences in Th1/Th2 cytokines were observed. Minor health complaints decreased in the EpiCor group compared to the placebo group (p<0.02). Seasonal allergies increased in the placebo group, but were not observed in the EpiCor group; this was reflected by increased serum IgE in the placebo group compared to the EpiCor group (p<0.13). We conclude that consumption of EpiCor supported the health of red blood cells and mucosal immune protection.
2. Jensen, G. S., et all. Anti-inflammatory properties of a dried fermentate in vitro and in vivo. J Med Food 2014, 18(3), 378-84. [Online reference: http://www.ncbi.nlm.nih.gov/pubmed/25105458]
The aim of this study was to document anti-inflammatory properties of a dried fermentate derived from Saccharomyces cerevisiae (EpiCor®), hereafter referred to as dried fermentate in vitro using cell-based bioassays, and in vivo using a skin irritation model in healthy humans. In vitro testing involved parallel assessment of primary human polymorphonuclear (PMN) cell formation of reactive oxygen species (ROS) and migration toward the inflammatory mediator Leukotriene B4. In vivo evaluation used a single-blind placebo-controlled design, where dermal histamine-induced inflammation was used as a model for the complex intercellular signals involved in the initiation, escalation, and resolution of the inflammatory response. Microvascular blood perfusion was evaluated using noninvasive laser Doppler probes applied to the inner forearms of 12 healthy human subjects, where parallel sites were treated with either dried fermentate or saline (placebo). Subjective scores of dermal irritation were also collected. Treatment of PMN cells in vitro resulted in reduced ROS formation and migratory activity toward Leukotriene B4. Clinical results demonstrated significantly reduced microvascular inflammatory responses to histamine-induced skin inflammation, and significantly reduced subjective scores of irritation at the inflamed sites treated with dried fermentate compared with the sites treated with placebo (P<.05). Treatment of inflammatory cells in vitro with dried fermentate resulted in reduced inflammatory responses. This was confirmed in vivo, suggesting that the dried fermentate facilitates the resolution of inflammatory responses. The effects using a topical skin model suggest that similar events may happen when the dried fermentate is introduced across mucosal membranes after consumption.
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