Dietary Fiber + Green Tea Extract for Alcohol Consumption

(SatTAC Trial)

Overseen By Jimikaye Courtney, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Weight control medications

Disqualifiers: Severe alcohol use disorder, Severe mental illness, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

55 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using weight control medications or if you have medical conditions or take medications for which alcohol is not allowed.

What data supports the effectiveness of the treatment Dietary Fiber + Green Tea Extract for alcohol consumption?

Research shows that green tea extract, a component of the treatment, can protect against early alcohol-induced liver injury by reducing oxidative stress and liver damage in animal studies. Additionally, green tea extract has been shown to inhibit alcohol absorption, which may help prevent liver damage. ^{1 2 3 4 5}

Is the combination of dietary fiber and green tea extract safe for human consumption?

Green tea extract, particularly its component EGCG, is generally safe when consumed in traditional amounts, but high doses can cause liver issues. It's recommended not to exceed 300 mg of EGCG per day from supplements, and to take it with food to avoid liver problems. ^{1 6 7 8 9}

How does the treatment of dietary fiber and green tea extract for alcohol consumption differ from other treatments?

This treatment is unique because it combines dietary fiber with green tea extract, which contains compounds like epigallocatechin gallate (EGCG) that may help reduce alcohol absorption and protect the liver from alcohol-induced damage by preventing oxidative stress. Unlike traditional treatments, this approach leverages the antioxidant properties of green tea to potentially mitigate liver injury caused by alcohol. ^{1 2 3 10 11}

What is the purpose of this trial?

The goal of this pilot study is to identify the role of satiety on responses to alcohol drinking using human subject laboratory methods. Satiety will be manipulated over two sessions using a dietary supplement (fiber+green tea) or a calorically matched placebo. Responses to an acute alcohol challenge are measured.

Research Team

Jimikaye Courtney, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals who consume alcohol. Specific eligibility criteria are not provided, but typically participants would need to be healthy adults willing to have their satiety manipulated and alcohol response measured over two sessions.

Inclusion Criteria

Meeting NIAAA criteria for current at-risk drinking (i.e., >7/14 drinks in one week for women/men, with at least one episode of 4+/5+ drinks in the past 30 days)

Willingness to complete laboratory sessions involving blood draws and alcohol administration

I am between 21 and 45 years old.

Exclusion Criteria

Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)

I cannot consume alcohol due to my medical condition or medications.

Pregnant, nursing, or trying to become pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dietary supplement or placebo followed by an alcohol challenge over two sessions

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Fiber + Green Tea Extract

Trial Overview The study tests how feeling full (satiety) affects reactions to drinking alcohol. Participants will take a dietary supplement with fiber and green tea or a placebo that has no active ingredients before an alcohol challenge in two separate sessions.

Participant Groups

Group I: placebo, then dietary supplement Experimental Treatment 3 Interventions

Participants receive a placebo supplement at the first study session (Aspartame sweetener mixed with water + aspartame capsule), then the next session they receive the dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions.

Group II: dietary supplement, then placebo Experimental Treatment 3 Interventions

Participants receive a dietary supplement at the first study session (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule), and then the next study session they receive the placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions.

Dietary Fiber + Green Tea Extract is already approved in United States, European Union for the following indications:

Approved in United States as Green Tea Extract for:

• Dietary supplement for general health and wellness
• Antioxidant properties

Approved in European Union as Green Tea Extract for:

• Food supplement for antioxidant purposes
• General health and wellness

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Research Society on Alcohol (RSA)

Collaborator

Trials

1

Recruited

60+

North Carolina Translational and Clinical Sciences Institute

Collaborator

Trials

61

Recruited

4,600+

Research Society on Alcohol

Collaborator

Trials

2

Recruited

110+

Findings from Research

In a study of 80 overweight, non-diabetic, and dyslipidemic patients with non-alcoholic fatty liver disease (NAFLD), supplementation with green tea extract (GTE) for 12 weeks led to significant improvements in body weight, liver enzymes, and inflammatory markers compared to a placebo.

GTE therapy resulted in a 67.5% regression of fatty liver changes observed through ultrasound, while the placebo group only showed a 25% regression, indicating GTE's potential as an effective treatment option for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic benefits of green tea extract on various parameters in non-alcoholic fatty liver disease patients. Hussain, M., Habib-Ur-Rehman, ., Akhtar, L.[2020]

In a study with male Wistar rats over 4 weeks, the antioxidant polyphenolic extract of green tea significantly reduced liver injury caused by alcohol, as indicated by lower serum ALT levels and reduced necrosis in the liver.

Green tea extract effectively blocked the accumulation of oxidative stress markers and inflammatory proteins associated with alcohol consumption, suggesting that it may protect the liver by preventing oxidative damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green tea extract protects against early alcohol-induced liver injury in rats. Arteel, GE., Uesugi, T., Bevan, LN., et al.[2007]

Gallated catechins from green tea extract (GTE) can significantly reduce blood ethanol and acetaldehyde levels when administered immediately before alcohol intake, suggesting a protective effect against alcohol toxicity.

Combining GTE with polyethylene glycol (PEG) or poly-γ-glutamate (PGA) enhances its effectiveness in preventing acute liver injury caused by binge drinking, indicating a potential new strategy for treating alcohol-related liver damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green tea extract co-administered with a polymer effectively prevents alcoholic liver damage by prolonged inhibition of alcohol absorption in mice. Park, JH., Kim, SJ., Hwang, I., et al.[2013]

(-)-epigallocatechin-3-gallate (EGCG), a major compound in green tea, is linked to various health benefits such as antioxidant effects, cancer prevention, and improved cardiovascular health, but effective concentrations often exceed those obtained from regular tea consumption.

Recent well-designed clinical studies have shown that both green tea extracts and purified EGCG can be effective in treating certain health conditions, highlighting the potential of these compounds in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epigallocatechin-3-gallate (EGCG): chemical and biomedical perspectives. Nagle, DG., Ferreira, D., Zhou, YD.[2022]

The fermented green tea extract (FGTE) significantly improved cell viability in HepG2 liver cells exposed to alcohol, indicating its potential protective effects against alcohol-induced liver damage.

In an in vivo mouse model, FGTE administration reduced blood alcohol levels and prevented increases in liver enzymes and triglycerides, suggesting it enhances alcohol metabolism and may help protect the liver from damage caused by alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green tea extract (Camellia sinensis) fermented by Lactobacillus fermentum attenuates alcohol-induced liver damage. Park, JH., Kim, Y., Kim, SH.[2022]

Green tea infusions and green tea extract (GTE) products are generally considered safe for consumption, with no association between green tea intake and liver damage in humans, even at doses up to 450mg of EGCG per day.

A proposed tolerable upper intake level of 300mg of EGCG per person per day for food supplements provides a significant safety margin, as clinical studies have shown no liver effects at intakes below 600mg per day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of green tea based beverages and dried green tea extracts as nutritional supplements. Dekant, W., Fujii, K., Shibata, E., et al.[2017]

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]

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]

Green tea catechins, particularly (-)-epigallocatechin-3-gallate (EGCG), are generally considered safe when consumed in amounts typical of traditional green tea infusions (90 to 300 mg/day), but high doses from supplements (800 mg/day or more) can lead to liver injury in some individuals.

The EFSA ANS Panel found that while most people can safely consume green tea catechins, rare cases of hepatotoxicity have been reported, likely due to individual reactions, highlighting the need for caution with high-dose supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scientific opinion on the safety of green tea catechins. Younes, M., Aggett, P., Aguilar, F., et al.[2023]

Green tea extract, particularly its main component epigallocatechin gallate (EGCG), has been studied for its potential health benefits, including anticancer and neuroprotective properties, with a focus on its safety and toxicity in various animal models.

The National Toxicology Program (NTP) conducted a comprehensive study on green tea extract, administering it to rats and mice over periods of 3 months to 2 years to assess its effects, ensuring relevance to human exposure through oral gavage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicology studies of green tea extract in F344/NTac rats and B6C3F1/N mice and toxicology and carcinogenesis studies of green tea extract in Wistar Han [Crl:WI(Han)] rats and B6C3F1/N mice (gavage studies). [2021]

A study on male ICR mice showed that a green tea extract (GTE) significantly reduced blood and liver levels of ethanol and acetaldehyde after ethanol consumption, indicating enhanced ethanol metabolism.

The components of GTE, particularly (-)-epigallocatechin gallate (EGCg) and caffeine, contributed to these effects, suggesting they play a role in improving how the body processes alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tea (Camellia sinensis) chemical compounds on ethanol metabolism in ICR mice. Kakuda, T., Sakane, I., Takihara, T., et al.[2018]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Therapeutic benefits of green tea extract on various parameters in non-alcoholic fatty liver disease patients. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Green tea extract protects against early alcohol-induced liver injury in rats. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Green tea extract co-administered with a polymer effectively prevents alcoholic liver damage by prolonged inhibition of alcohol absorption in mice. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Epigallocatechin-3-gallate (EGCG): chemical and biomedical perspectives. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Green tea extract (Camellia sinensis) fermented by Lactobacillus fermentum attenuates alcohol-induced liver damage. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety assessment of green tea based beverages and dried green tea extracts as nutritional supplements. [2017]

7. Ireland pubmed.ncbi.nlm.nih.gov

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

8. 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]

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

Scientific opinion on the safety of green tea catechins. [2023]

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

Toxicology studies of green tea extract in F344/NTac rats and B6C3F1/N mice and toxicology and carcinogenesis studies of green tea extract in Wistar Han [Crl:WI(Han)] rats and B6C3F1/N mice (gavage studies). [2021]

11. England pubmed.ncbi.nlm.nih.gov

Effects of tea (Camellia sinensis) chemical compounds on ethanol metabolism in ICR mice. [2018]