Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

Last updated: March 26, 2025
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Substance Abuse

Alcohol Use Disorder

Alcohol Dependence

Treatment

Generally Recognized as Safe - Sulforaphane

Placebo

Clinical Study ID

NCT05902754
1268
U24DK132740
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Chronic alcohol consumption leads to perturbations in gut microbiome balance (dysbiosis) and disruption of gut barrier integrity. As a result, bacteria, toxins, and metabolites can enter the blood stream and reach distant organs, triggering inflammation and oxidative stress. Through this mechanism gut leak is closely related to the onset of metabolic diseases, such as nonalcoholic fatty liver disease (NAFLD) and diabetes.

Despite the prominent role of diet and alcohol in the pathogenesis of metabolic diseases, there is a lack of treatments to mitigate their effects in triggering systemic inflammation and oxidative stress. Novel treatments using generally recognized as safe (GRAS) compounds focused on restoring the intestinal barrier to mitigate metabolite endotoxemia are sorely needed. This project will test the potential of broccoli sprouts extract (BSE) as a GRAS treatment to minimize the combined effect of poor nutrition and alcohol on the gut. Broccoli sprouts are rich in sulforaphane, a bioactive compound derived from the glucosinolate glucoraphanin with anti-inflammatory and antioxidant proprieties. BSE supplementation has been used in preclinical and clinical studies as a health- promoting food, showing significant positive changes in the gut microbiota composition, protection against colitis, cardiometabolic improvement, and lower inflammation. We believe that BSE is a viable alternative therapeutic approach for patients who are resistant to lifestyle changes such as healthy eating and reducing alcohol use. Our purpose is to test BSE supplementation in human subjects with poor nutrition compounded by alcohol use, specifically in older adults who we believe will receive greater benefit from this approach. At the completion of the proposed study, we expect to have determined that treatments using generally recognized as safe (GRAS) compounds can be useful to restore the gut barrier integrity, and as consequence of reduced gut leak we expect to observe lower inflammation and oxidative stress.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects ≥ 50 years of age at enrollment.

  • Consume at least 8 alcoholic drinks/week. AUDIT-C score >8.

Exclusion

Exclusion Criteria:

  • Bowel-related diseases

  • Diagnosed Diabetes

  • Allergy or intolerance to broccoli.

  • Any acute illness within the last 6 weeks.

  • Chronic anti-inflammatory use or antibiotic treatment in the last 7 days.

  • Acute illness within the preceding six weeks (defined as fever, new antibiotic useor unscheduled healthcare visit - for illness).

  • Acute alcohol intoxication upon arrival on the day of study visit.

Additional exclusion criteria:

• Any health issue that, the study investigator's judgement, confers excess risk for participation.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Generally Recognized as Safe - Sulforaphane
Phase:
Study Start date:
January 23, 2024
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Louisiana Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.