Hadassah researchers have demonstrated that cow Colostrum, the milk produced immediately after calving, enriched with insulin antibodies, dramatically lowers the level of sugar and insulin resistance in mice with a model of fatty liver disease.
Dr. Tomer Adar and Dr. Gadi Lalazar of Hadassah’s Department of Internal Medicine headed the team that conducted the research at Hadassah Ein Kerem in Jerusalem. They are presenting their findings in Boston this week at the annual conference of the American Association for the Study of Liver Diseases (AASLD.) Over 7,000 researchers from 55 countries attend the conference. Eight Hadassah doctors will present 14 reports at the conference.
Fatty Liver Disease is characterized by the development of a surplus of fat in the liver cells. It is caused mainly by obesity, diabetes and hyperlipidemia – elevation of lipids in the bloodstream – mostly tryglicerides. Insulin Resistance, the relationship between these factors and the disease, occurs when cells do not react normally to insulin, increasing the level of sugar and hyperlipidemia in the body. Fatty liver disease is the most common liver disease in the western world and is becoming increasingly prevalent in other parts of the world as well.
Earlier this year, Hadasit, the technology transfer arm of the Hadassah Medical Organization, and Immuron, an Australian biopharmaceutical company, signed an agreement to develop the Hadassah research. The collaborative effort combines Hadassah’s oral immune modulation approach with antibodies produced by Immuron. The result appears to directly affect the activity level of regulatory T cells—a type of immune cell known to have a profound effect on controlling inflammation—in the liver and fat tissues, lowering the level of sugar and improving insulin resistance.
Prof. Yaron Ilan, Head of Hadassah's Department of Internal Medicine A, who serves as the medical director of Immuron, developed the new technology. “We were able to demonstrate dramatic improvement in the levels of sugar and hyperlipidemia on an animal model with fatty liver disease. These encouraging results reinforce our ability to investigate the use of this concept on other inflammatory processes”, he said.
Hadassah researchers will initiate a clinical trial to test the safety and efficacy of the new treatment on human patients with fatty liver disease within a few months.
Results of Metadoxine Clinical Trial
Have Important Implications for Alcohol Drinkers
A Phase 1 clinical trial conducted at Hadassah Ein Kerem showed that ingesting one dose of a new slow-release Metadoxine formula before consuming alcohol lowered the level of alcohol in the blood, dramatically improved motor and cognitive functions and decreased the craving for alcohol in the test participants. Metadoxine, a substance currently used to treat alcoholic addiction, is only effective for about 50 minutes. The slow-release formula was developed by Alcobra Ltd., an Israeli start-up company.
The clinical trials were conducted by researchers from Hadassah’s Liver Unit and Department of Psychiatry. Dr. Meir Mizrahi and Dr. Gadi Lalazar of Hadassah’s Department of Internal Medicine A, who headed the research team, presented their findings at the American Association for the Study of Liver Diseases (AASLD) conference in Boston.
After a ten-hour fast, the six participants in the first phase of the clinical trial took one dose of the slow-release Metadoxine formula (1,190 – 2,100 ml.) and then drank 70 ml. of alcohol. During the 12-hour follow-up/observation period, blood was drawn for alcohol and Metadoxine levels, and the subjects were graded on a driving simulator, a continuous performance test used to diagnose ADHD, memory and cognitive skills. They also answered a questionnaire regarding their level of craving for alcohol.
All of participants had a decreased blood level of alcohol and the results of their motor and cognitive tests were positive.
The researchers believe that slow-release Metadoxine formula can assist in the treatment of alcoholism and its side effects. They are planning to enlarge the scope of their study in the next phase of their trial in the coming months.
The Hadassah-Alcobra project is being conducted under the auspices of Hadasit, Hadassah's technology transfer company.