Pomegranate supplements and gut bacteria in alcohol use disorder and alcohol-related liver disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in one of four groups: healthy people, people with alcohol use disorder (AUD), people with early alcohol-related liver disease, or people with alcohol-related cirrhosis (liver scarring). All take a pomegranate supplement.

Age

18 Years and older

Sex

All sexes

Disease stage

Healthy group: no AUD or liver disease. AUD group: AUD diagnosis. Early liver disease group: AUD plus early alcohol-related liver disease. Cirrhosis group: alcohol-related cirrhosis with AUD.

Biomarker or test result

Early liver disease group: ALT (a liver blood test) above 40.

Main reasons for not taking part

• Healthy group: AUD, alcohol-related liver disease, cirrhosis or inflammatory conditions
• AUD group: health problems in the body caused by alcohol
• Early liver disease group: AUD only, or AUD with cirrhosis
• Cirrhosis group: AUD only, or early-stage liver disease

The registry criteria, word for word

What the trial wants to find out

The goal of this project is to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. Recent publications have reported that urolithins are the major active metabolites responsible for the beneficial effects of eating pomegranates, berries, or walnuts. However, the production of urolithins from the parent compound ellagic acid (EA) is dependent upon the presence of certain bacteria in the human gut. In this trial, we propose to investigate variations in gut microbiota and their capacity to metabolize pomegranate dietary supplements (PDS) into active urolithins. We will measure the levels of urolithins in blood as well as inflammatory cytokines in plasma samples upon consumption of PDS.

The 4 groups in the trial

• healthy volunteers

  Adults ≥18, Drink no alcohol or drink \< 50 grams of alcohol per day on average if female and \< 80 grams per day on average if male; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg

  Treatment: Pomegranate Dietary Ssupplement

• Alcohol Use Disorder (AUD) subjects

  Adults ≥18; Must consume \>20 standardized alcoholic beverages a week for the last 3 months for men, \>14 standard alcoholic beverages a week for women; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg

  Treatment: Pomegranate Dietary Ssupplement

• Alcoho-associated Cirrhosis (AC) patients

  Adults ≥18; A history of alcohol consumption averaging at least 80 grams per day in men or 50 grams per day for women for at least 10 years; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg

  Treatment: Pomegranate Dietary Ssupplement

• Early-Stage Alcohol-Associated Liver Disease

  Adults ≥18; AUD qualifying criteria, plus ALT\>40. 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg

  Treatment: Pomegranate Dietary Ssupplement