INTRODUCTION METHODS RESULTS CONCLUSION

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INTRODUCTION METHODS RESULTS CONCLUSION Decreased IL-6 and TNF-a secretion and increased GLP-1 and CD4+CD25+Foxp3+ T cells in response to oral administration of Hoodia parviflora alleviates insulin resistance and liver damage: Results of a Phase I clinical trial Meir Mizrahi, Ami Ben Ya'acov, Tomer Adar, Gadi Lalazar, Yehudit Shabat, Refael Aharon, Yaron Ilan*. Liver Unit, Department of Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Desert Labs Israel. Day 0 Day 30 INTRODUCTION Metabolic syndrome is a chronic inflammatory disorder associated with insulin resistance and hepatic steatosis. Extracts of the succulent Hoodia parviflora (HP) exert an immunomodulatory effect alleviating target organ damage in rodents. Aim: To determine the safety and efficacy of oral administration of HP extracts to patients with insulin resistance and NAFLD. CD4+CD25+ cells (p<0.01) improved cholestatic liver enzymes levels p<0.04. p<0.002 TG levels (p<0.05) Day 30 Day 0 METHODS Open-label trial. HP was daily orally administered to 10 patients for 30 days. Subjects were monitored for safety, and serum levels of TNF-a, IL-6, adiponectin, GLP-1 and for the specific phenotypic markers of regulatory T cells in their PBMCs. The clinical effect was evaluated using by following oral glucose tolerance test (OGTT), liver enzyme and serum lipid profile. All parameters were followed on day o and 30. analysis was carried out on responders. CD4+CD25+ FOXp3 cells (p<0.01) Total Cholesterol levels (p<0.05) LDL levels (p<0.01) Day 0 Day 30 Insulin secretion at 30 min (p<0.003) OGTT (AUC p<0.002) CD4+CD62+ cells (p<0.03) RESULTS CONCLUSION Oral administration of HP is safe and exerts an immunomodulatory effect in patients with type 2 diabetes, hyperlipidemia and NASH. The anti-inflammatory effect and the induction of Tregs are associated with alleviation of insulin resistance, hyperlipidemia, and liver damage in these patients. TNF α levels (p<0.05) IL-6 levels (p<0.05) Administration of Imm122-E improved hepatocellular liver enzymes levels p<0.04. DISCLOSURE * Medical Director of Desert Labs. The study was supported by Desert Labs Ltd, Israel GLP-1 levels (p<0.03) Improved in BMI (p<0.05)