DHM for Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and optimal dosage of a compound called dihydromyricetin (DHM) for potential liver disease treatment. Researchers are testing various doses of DHM, both alone and with lysine, to understand how the body processes it and to determine the maximum safe dose. The study is open to healthy volunteers without a history of liver disease or alcohol use disorder. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
If you are taking drugs that affect CYP3A4 (a liver enzyme), you will need to stop taking them to participate in this trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Dihydromyricetin (DHM) is generally safe for people. According to a source from the NIH, early trials reported no major side effects from DHM. It is often used for liver health and has shown potential in protecting against liver damage in animal studies.
DHM is also being tested with Lysine, an amino acid that helps the body build proteins. While specific human data on this combination is not yet available, past studies have found DHM alone to be safe. However, like many herbal supplements, more research is needed to fully understand its safety in humans.
This trial is in the early stages, focusing mainly on assessing the treatment's safety. Although human data is limited, DHM's positive results in other studies are promising.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Dihydromyricetin (DHM) for liver disease because it offers a novel approach compared to standard treatments like antiviral medications and lifestyle changes. DHM is unique because it is derived from natural sources and is being tested both alone and in combination with lysine, which could enhance its effects. Unlike traditional treatments that often focus on managing symptoms or controlling disease progression, DHM might provide a more direct protective effect on liver cells. This approach could lead to faster and potentially more sustainable improvements in liver health.
What evidence suggests that this trial's treatments could be effective for liver disease?
Research suggests that dihydromyricetin (DHM) may benefit liver health. In a small study involving individuals with nonalcoholic fatty liver disease, DHM improved certain liver health indicators in their blood. It also reduced liver inflammation and fat buildup. Animal studies indicate that DHM can help the liver recover from alcohol-related damage. In this trial, participants will receive different doses of DHM, with some groups also receiving lysine. Combined with lysine, DHM might offer extra protection to liver cells by reducing damage and inflammation. These findings suggest DHM could help with liver issues, but more research in humans is needed.16789
Who Is on the Research Team?
Brian Lee, MD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
This trial is for healthy volunteers aged 18-60 with no history of alcohol use disorder or liver disease. Participants must weigh over 50kg and not have acute illnesses, pancreatic/biliary diseases, advanced liver conditions, HIV, other liver diseases, or be pregnant. They also shouldn't be on drugs affecting CYP3A4 enzymes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of DHM, with pharmacokinetic and safety assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dihydromyricetin
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor