1. 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)