Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH

Nonalcoholic steatohepatitis (NASH) is considered to be part of the nonalcoholic fatty liver disorders and its incidence is increasing. Imm124-E (Immuron Ltd, Melbourne, Australia), containing hyperimmune bovine colostrum, has been shown to exert an immunomodulatory effect and to alleviate target or...

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Published inJournal of inflammation research Vol. 5; no. default; pp. 141 - 150
Main Authors Mizrahi, Meir, Shabat, Yehudit, Ben Ya'acov, Ami, Lalazar, Gadi, Adar, Tomer, Wong, Victor, Muller, Brian, Rawlin, Grant, Ilan, Yaron
Format Journal Article
LanguageEnglish
Published New Zealand Taylor & Francis Ltd 01.01.2012
Dove Press
Dove Medical Press
Subjects
adipokines
anti-LPS
Clinical trials
diabetes
Glucose
Insulin resistance
NASH
Original Research
regulatory T cells
regulatory T cells
adipokines
anti-LPS
NASH
diabetes
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Summary:Nonalcoholic steatohepatitis (NASH) is considered to be part of the nonalcoholic fatty liver disorders and its incidence is increasing. Imm124-E (Immuron Ltd, Melbourne, Australia), containing hyperimmune bovine colostrum, has been shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models of NASH. The aim of our study was to determine the safety and efficacy of oral administration of Imm124-E to patients with insulin resistance and NASH. In an open-label trial, ten patients with biopsy-proven NASH and insulin resistance were orally treated with Imm124-E for 30 days. Oral administration of Imm124-E was safe, and no side effects were noted. Alleviation of insulin resistance was reflected by significantly improved hemoglobin A(1c) (HbA(1c)) values in all ten treated patients. For between five and eight responders, the following effects were noted: a decrease in fasting glucose levels; improved oral glucose tolerance test (OGGT) and homeostatic model assessment insulin resistance (HOMA) scores; and alleviation in lipid profile. These effects were accompanied by increased serum levels of glucagon-like peptide 1 (GLP-1), adiponectin and T regulatory cells. Hyperimmune colostrum alleviates NASH.
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ISSN:1178-7031
1178-7031
DOI:10.2147/JIR.S35227