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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 . • 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. INTRODUCTION 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. Insulin secretion at 30 min (p<0.003) Administration of Imm122-E improved hepatocellular liver enzymes levels p<0.04. 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) Improved in BMI (p<0.05) RESULTS improved cholestatic liver enzymes levels p<0.04. p<0.002 OGTT (AUC p<0.002) TG levels (p<0.05) DISCLOSURE GLP-1 levels (p<0.03) CD4+CD25+ cells (p<0.01) CD4+CD25+ FOXp3 cells (p<0.01) CD4+CD62+ cells (p<0.03) * Medical Director of Desert Labs. The study was supported by Desert Labs Ltd, Israel 0.0 20.0 40.0 60.0 80.0 Day 0 DAY 30 ALTlevels(U/m l) 0.0 20.0 40.0 60.0 80.0 100.0 Day 0 DAY 30 ASTlevels(U/ml) 0.0 20.0 40.0 60.0 80.0 100.0 Day 0 DAY 30 GGT levels (U/m l) 0 0.5 1 1.5 2 2.5 D ay 0 DAY 30 TG levels(µm ol/L) 4.5 4.6 4.7 4.8 4.9 5 5.1 5.2 5.3 5.4 D ay 0 DAY 30 TotalC holesterollevels(µm ol/L) Total Cholesterol levels (p<0.05) 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 D ay 0 DAY 30 Total C holesterol levels(µm ol/L) LDL levels (p<0.01) 0 100 200 300 400 500 600 700 800 900 1000 D ay 0 DAY 30 Early insulin secretion(pg/m l) 0 500 1000 1500 2000 2500 D ay 0 DAY 30 O G TT (area underthe curve) 0 1 2 3 4 5 6 7 8 D ay 0 DAY 30 TN F-alpha levels (pg/m l) 0 1 2 3 4 5 6 7 8 9 D ay 0 DAY 30 IL-6 levels (pg/m l) IL-6 levels (p<0.05) 25.5 26 26.5 27 27.5 28 28.5 29 D ay 0 DAY 30 G LP-1 levels (pM ) 28.5 29 29.5 30 30.5 31 31.5 32 32.5 D ay 0 DAY 30 Im provm entin B M I Day 30 Day 0 0 1 2 3 4 5 6 D ay 0 DAY 30 CD4+CD25+G ated cells Day 30 Day 0 0 0.5 1 1.5 2 2.5 3 D ay 0 DAY 30 CD4+CD25+FO Xp3 G ated cells Day 0 Day 30 0 5 10 15 20 25 30 35 40 45 D ay 0 DAY 30 CD4+CD62+ G ated cells

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Decreased IL-6 and TNF-a secretion and increased GLP-1 and CD4+CD25+Fox p3+ T cells in response to oral administration of Hoodia parviflora alleviates insulin resistance and liver damage: Results of a Phase I clinical trial. - PowerPoint PPT Presentation

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  • 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 trialMeir 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. 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. INTRODUCTIONMETHODSOpen-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.Insulin secretion at 30 min (p

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