A medical food is a non-drug formula that may contain only ingredients that are found on the FDA's GRAS (Generally Regarded As Safe) List. The complete list of HepAssure Medical Food ingredients may be found HERE.
HepAssure is a medical food for Patients with Chronic Liver Disease (CLD). CLD includes a wide list of liver diseases including Non-Alcoholic Fatty Liver Disease/Non-Alcoholic SteatoHepatitis (NAFLD/NASH), Alcohol Liver Disease, Hepatitis C and Hepatitis B.
The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
A medical food may fulfill the new and distinct nutritional requirements of the patient, but may not treat or cure the underlying disease.
HepAssure is a medical food that is based on established scientific studies that show that all different types of Chronic Liver Diseases change the metabolism of CLD patients in very similar ways.
These alterations involve up-regulation of certain specific metabolic pathways in the patient. These changes to the metabolism, in turn alter the nutritional requirements of the patient.
In other words, patients with CLD have different nutritional requirements than normal healthy people. HepAssure is designed to fulfill the new distinctive nutritional requirements of the CLD patient.
The HepAssure/HonorHealth Human Clinical Trial is designed to investigate whether HepAssure medical food satisfies the new distinctive nutritional requirements of the CLD Patient. The clinical trial will assess a number of parameters, including blood tests and liver fibrosis assessment by Fibroscan liver elastography at The LiverLab Fibroscan Clinic.
HepAssure is not intended to cure or treat CLD. HepAssure is designed to satisfy the nutritional requirements of CLD patients. The intended purpose of HepAssure Medical Food is down-regulation of secondary fibrogenic amplification, caused by unfulfilled nutritional requirements (click here). In this way satisfaction of a CLD patient's new and distinctive nutritional requirements by HepAssure medical food may be shown as a decrease in liver fibrosis staging over time.
Please call The Liverlab at 844-254-8375 if you would like to be screened for enrollment in either of the HepAssure Human Clinical Trials. The clinical trials do not cost anything to the patients besides what is ordinarily covered by the Patient's medical insurance. All HepAssure product is provided free of charge to the patient.