Alcohol and Sugar Impact on Liver Metabolism

Overseen By Lucy H Christie, BSN, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Any regular medications

Disqualifiers: BMI >29.9, Comorbid conditions, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

27 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any regular medications, except for oral contraceptives, to participate in this trial.

What data supports the effectiveness of the treatment involving ethanol and sugar on liver metabolism?

The research indicates that ethanol can cause liver damage, such as fatty liver and alcoholic hepatitis, in animal models. However, there is no evidence from the provided studies that ethanol or sugar has a beneficial effect on liver metabolism. ^{1 2 3 4 5}

Is ethanol (ETOH) safe for liver metabolism?

Ethanol (ETOH) can cause liver damage, including fatty liver and impaired liver cell replication, especially with excessive consumption. It is considered a hepatotoxin, meaning it can be toxic to the liver, and can lead to liver injury when combined with high-sugar diets. ^{2 5 6 7 8}

How does the drug ETOH differ from other treatments for liver metabolism issues?

ETOH (ethanol) is unique because it can diminish the increase in glucose production and utilization caused by endotoxins, which is not a typical feature of other treatments for liver metabolism issues. This effect is due to ethanol's ability to inhibit hepatic glucose production and peripheral glucose utilization. ^{1 2 6 9 10}

What is the purpose of this trial?

The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of \[2H\]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.

Eligibility Criteria

This trial is for healthy men and women aged 21-45, with a BMI of 18.5-29.9, who drink alcohol lightly to moderately. They must understand English but can't participate if they're pregnant, breastfeeding, have a high BMI (>29.9), take regular medications (except oral contraceptives), or exercise heavily.

Inclusion Criteria

Ability to speak and understand English

Ages 21 - 45

You have a normal nutritional status.

Exclusion Criteria

BMI >29.9

You have other health conditions in addition to the one being studied.

You are pregnant or currently breastfeeding a child.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume deuterated water and alcohol or sucrose beverages, with blood samples collected to measure hepatic de novo lipogenesis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• ETOH
• Sucrose

Trial Overview The study tests how the liver creates fat after drinking alcohol by having participants consume deuterated water and then vodka. Blood samples will be taken before and after this process in two groups: one also consuming sucrose with vodka and another with sucrose alone.

Participant Groups

Group I: ETOH + Sucrose Experimental Treatment 2 Interventions

5 Females will receive deuterated water and drink 1.72 ounces of alcohol in the form of vodka + 7 grams of sucrose and have de novo Lipogenesis measured at 11 time points during and after.

Group II: C. Sucrose Experimental Treatment 1 Intervention

5 Females will receive deuterated water and drink a solution containing water and 35 grams of sucrose, and have de novo Lipogenesis measured at 11 time points during and after.

Group III: A. ETOH Experimental Treatment 1 Intervention

5 Males and 5 Females will receive deuterated water and drink 2.15 ounces of alcohol in the form of vodka and have de novo Lipogenesis measured at 11 time points during and after.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

References

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

Animal models of ethanol dependence and liver injury in rats and baboons. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Ethanol administration diminishes the endotoxin-induced increase in glucose metabolism. [2019]

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

A new oral low-carbohydrate alcohol liquid diet producing liver lesions: a preliminary account. [2019]

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

Alcoholic liver injury: experimental models in rats and baboons. [2019]

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

Methylation and gene expression responses to ethanol feeding and betaine supplementation in the cystathionine beta synthase-deficient mouse. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Interrelationships between the metabolic effects of glucagon and ethanol in the perfused mouse liver. [2014]

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

Evaluating the effects of refined carbohydrate and fat diets with acute ethanol consumption using a mouse model of alcoholic liver injury. [2018]

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

Effects of ethanol on hepatic cellular replication and cell cycle progression. [2019]

9. Ireland pubmed.ncbi.nlm.nih.gov

Aldose reductase inhibitor protects mice from alcoholic steatosis by repressing saturated fatty acid biosynthesis. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

[Metabolic aspects of alcoholic liver damage: 1984/5 update. 1. Epidemiology and alcohol metabolism]. [2013]