Green Tea Extract for Liver Cirrhosis

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents

Disqualifiers: HCC, Other cancer, Decompensated liver, others

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

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

14 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not take supplements or foods labeled as containing green tea for 8 weeks before starting the treatment.

What data supports the effectiveness of the treatment Defined Green Tea Catechin Extract for liver cirrhosis?

Research shows that green tea extract can protect against liver damage and cirrhosis in animal models, and its components, like catechins, have been found to improve liver function and reduce inflammation in conditions similar to liver cirrhosis, such as non-alcoholic fatty liver disease. ^{1 2 3 4 5}

Is green tea extract safe for the liver?

Green tea extract can cause liver problems in some people, especially if taken on an empty stomach or in high doses. It's important to take it with food and avoid it if you have liver issues. Most liver-related side effects are mild, but serious problems are rare. ^{1 6 7 8 9}

How does the green tea extract treatment for liver cirrhosis differ from other treatments?

Green tea extract is unique because it contains catechins, especially (-)-epigallocatechin gallate (EGCG), which have antioxidant and anti-fibrotic properties that help protect and repair liver tissue. Unlike many standard treatments, it is derived from a natural source and has shown potential in reversing liver damage in animal models. ^{1 2 7 10 11}

What is the purpose of this trial?

This trial studies the effects of a green tea extract on people with cirrhosis. The goal is to find the best dose and see if it can lower a molecule linked to liver cancer. By reducing this molecule, the treatment may help prevent liver cancer in these patients. Green tea extract has been shown to protect against various forms of liver damage, including those induced by alcohol, acetaminophen, and carbon tetrachloride.

Research Team

Aiwu R He

Principal Investigator

Northwestern University

Eligibility Criteria

Adults diagnosed with cirrhosis who can undergo imaging tests like ultrasound, CT, or MRI. They must have a good performance status (able to carry out daily activities), adequate blood counts and liver function, no history of certain cancers within the last 3 years except some localized ones, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with bleeding risks, allergies to green tea components, recent consumption of green tea products, other active cancers requiring systemic treatment or hepatic decompensation events.

Inclusion Criteria

I can undergo scans for my condition.

I am fully active or can carry out light work.

I do not have fluid buildup in my abdomen or brain function issues.

Exclusion Criteria

I am mentally capable of understanding and consenting to treatment.

Recent consumption of green tea-containing supplements or foods

I cannot swallow pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive defined green tea catechin extract orally once or twice daily for 24 weeks

24 weeks

Regular visits for imaging and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Defined Green Tea Catechin Extract

Trial Overview The trial is testing defined green tea catechin extract's ability to prevent liver cancer in cirrhotic patients by lowering gamma-OHPdG levels. Participants will receive varying doses of this extract while being monitored through imaging studies and laboratory biomarker analysis for any changes in their condition.

Participant Groups

Group I: Prevention (defined green tea catechin extract) Experimental Treatment 9 Interventions

Participants receive defined green tea catechin extract PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound, CT, or MRI at screening and on study, undergo collection of blood samples on study, and may undergo biopsy at screening and on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a 12-week study involving 17 patients with non-alcoholic fatty liver disease (NAFLD), consumption of green tea with high-density catechins significantly reduced body fat and improved liver health, as indicated by better liver-to-spleen CT attenuation ratios.

The high-density catechin group also showed significant decreases in serum alanine aminotransferase (ALT) levels and urinary 8-isoprostane excretion, suggesting that green tea may help reduce liver inflammation and oxidative stress in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green tea with high-density catechins improves liver function and fat infiltration in non-alcoholic fatty liver disease (NAFLD) patients: a double-blind placebo-controlled study. Sakata, R., Nakamura, T., Torimura, T., et al.[2014]

The systematic review found that while green tea extracts (GTE) can contain potentially harmful substances, there was no direct evidence linking these contaminants to liver injury, although hepatotoxicity has been associated with high doses of EGCG (140 mg to 1000 mg/day).

Due to the risk of liver injury, the United States Pharmacopeia now recommends that GTE should not be taken on an empty stomach and advises against use in individuals with liver problems, highlighting the importance of taking GTE with food and monitoring for symptoms of liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts. Oketch-Rabah, HA., Roe, AL., Rider, CV., et al.[2020]

References

1. China pubmed.ncbi.nlm.nih.gov

[Green tea extracts protected against carbon tetrachloride-induced chronic liver damage and cirrhosis]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Antifibrotic effects of green tea on in vitro and in vivo models of liver fibrosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Therapeutic potential of green tea in nonalcoholic fatty liver disease. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Epigallocatechin gallate attenuates fibrosis, oxidative stress, and inflammation in non-alcoholic fatty liver disease rat model through TGF/SMAD, PI3 K/Akt/FoxO1, and NF-kappa B pathways. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Green tea with high-density catechins improves liver function and fat infiltration in non-alcoholic fatty liver disease (NAFLD) patients: a double-blind placebo-controlled study. [2014]

6. Ireland pubmed.ncbi.nlm.nih.gov

United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Green tea extract and the risk of drug-induced liver injury. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The safety of green tea and green tea extract consumption in adults - Results of a systematic review. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials. [2018]

10. Greece pubmed.ncbi.nlm.nih.gov

Curative propensity of green tea extract towards hepatic fibrosis induced by CCl(4): A histopathological study. [2021]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Green tea extract-patents and diversity of uses. [2019]