Decreased IL-6 and TNF-a secretion and increased GLP-1 and CD 4+CD 25+Foxp 3+ 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 INTRODUCTION Day 30 • 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 CD 4+CD 25+ cells (p<0. 01) improved cholestatic liver enzymes levels p<0. 04. p<0. 002 TG levels (p<0. 05) Day 0 administration of HP extracts to patients with insulin resistance and NAFLD. Day 30 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. CD 4+CD 25+ FOXp 3 cells (p<0. 01) Total Cholesterol levels (p<0. 05) LDL levels (p<0. 01) Day 0 Day 30 • analysis was carried out on responders. RESULTS Insulin secretion at 30 min (p<0. 003) OGTT (AUC p<0. 002) CD 4+CD 62+ cells (p<0. 03) CONCLUSION TNF α levels (p<0. 05) IL-6 levels (p<0. 05) Administration of Imm 122 -E improved hepatocellular liver • 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. DISCLOSURE enzymes levels p<0. 04. GLP-1 levels (p<0. 03) Improved in BMI (p<0. 05) * Medical Director of Desert Labs. The study was supported by Desert Labs Ltd, Israel