Cholates for Liver Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baylor Research Institute

Disqualifiers: Hepatic encephalopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using cholates (a type of bile acid) for individuals with end-stage liver disease. The goal is to improve the assessment and treatment of liver disease by expanding the range of tests used to evaluate patients. This approach could help doctors provide more accurate predictions and treatment plans. Individuals with end-stage liver disease, advanced liver damage, or those who are living liver donors might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in liver disease treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that cholates are likely to be safe for humans?

Research shows that certain substances in dark chocolate, called cholates, might benefit the liver. Studies have found that dark chocolate can support liver health by improving blood flow and assisting with conditions like non-alcoholic fatty liver disease (NAFLD).

In earlier studies, people with liver disease who consumed dark chocolate experienced a positive change in liver blood pressure after meals. This suggests that cholates might enhance liver function without causing harm.

However, some dark chocolate can contain harmful metals like lead and cadmium, so the source of the cholates is important.

Overall, these findings are promising. However, consulting a healthcare professional before joining a trial or making significant dietary changes is always wise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cholates are unique because they explore a new approach to treating liver disease by using bile acid derivatives. Unlike standard treatments that primarily focus on managing symptoms or slowing disease progression, cholates aim to restore liver function by enhancing bile flow and improving liver cell health. Researchers are excited about this treatment because it could offer a more targeted and potentially more effective solution, addressing the underlying issues in liver disease rather than just alleviating symptoms.

What evidence suggests that cholates might be an effective treatment for liver disease?

This trial will evaluate the effects of Cholates on liver disease. Although this trial does not involve dark chocolate, research has shown that dark chocolate might aid liver disease. Studies have found that dark chocolate can improve blood flow to the liver and reduce liver stress after meals in people with cirrhosis. One study discovered that eating dark chocolate lowered certain liver enzymes and signs of liver damage. Additionally, dark chocolate reduced substances in the blood that can signal liver problems. These findings suggest that dark chocolate could be a useful part of liver disease treatment, particularly for improving liver function and reducing liver-related stress. ^{1 3 6 7 8}

Who Is on the Research Team?

James Trotter, MD

Principal Investigator

Baylor Health Care System

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 with end-stage liver disease, living liver donors, or those with congenital heart disease. Participants must be able to give written consent and follow study rules. Only patients with severe fibrosis as shown by specific tests or clinical evidence can join.

Inclusion Criteria

My liver disease is in an advanced stage, indicated by severe scarring.

I have end-stage liver disease, am a living liver donor, or have congenital heart disease.

I am willing and able to follow the study requirements and have provided written consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the dual cholate test to assess liver function, including oral and intravenous cholate clearance and cholate shunt fraction measurement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cholate test

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cholates

Trial Overview The trial is testing new quantitative liver function tests using cholates. These tests aim to better evaluate the condition of patients with advanced liver disease and could help in managing their treatment and predicting outcomes more accurately.

How Is the Trial Designed?

Group I: Cholates Compound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4975527/

Dark Chocolate may Improve NAFLD and Metabolic ... Chocolate consumption, especially dark chocolate is associated with lowering of lipid peroxidation and thereby improving cardiovascular risk.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523029672

results of a phase 2, double-blind, randomized controlled trial Conclusion: In patients with cirrhosis, dark chocolate blunted the postprandial increase in HVPG by improving flow-mediated hepatic vasorelaxation and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3227569/

The effect of cocoa supplementation on hepatic steatosis ... Red blood cell glutathione was increased by cocoa supplementation, whereas liver glutathione was reduced by cocoa compared to methionine choline ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286321000383

Dietary cocoa ameliorates non-alcoholic fatty liver disease ... Consumption of 40 g/d dark chocolate was shown to lead to a significant decrease in plasma 8-isoprostane, alanine aminotransferase (ALT), and soluble NADPH ...

5. researchgate.net researchgate.net/publication/289497685_The_Effects_of_Dark_Chocolate_Consumption_on_Lipid_Profile_Fasting_Blood_Sugar_Liver_Enzymes_Inflammation_and_Antioxidant_Status_in_Patients_with_Non-Alcoholic_Fatty_Liver_Disease_A_Randomized_Placebo

(PDF) The Effects of Dark Chocolate Consumption on Lipid ... CONCLUSION: DC consumption can decrease the level of AST in patients with NAFLD and could be a potential therapeutic approach. We recommend more ...

6. healthday.com healthday.com/healthday-tv/general-health/some-dark-chocolate-products-contaminated-with-heavy-metals-new-study-finds

Some Dark Chocolate Products Contaminated With Heavy ... Researchers tested dozens of dark chocolate and cocoa products and found excessive levels of lead and cadmium in many of them.

7. news-medical.net news-medical.net/news/20241209/Tea-apples-and-chocolate-proven-to-support-liver-health.aspx

Tea, apples, and chocolate proven to support liver health A flavonoid-rich diet, including apples, tea, and dark chocolate, significantly lowers the risk of non-alcoholic fatty liver disease (NAFLD) ...

8. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)02967-2/pdf

Postprandial effects of dark chocolate on portal hypertension ... This “dynamic” component accounts for as much as 30% of total liver resistance in cirrhosis and represents a novel target for therapy (4, 5).