Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

NCT05902754 | Completed Results

• 2 other identifiers: 1268U24DK132740
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

Inflammation; Leaky gut; Supplements

Outcome Measures

Primary Outcomes (1)

• Gut Leak

  Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.

  Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.

Secondary Outcomes (1)

• Biomarkers of Inflammation

  After 28 days of treatment

Other Outcomes (3)

• Oxidative Stress Markers - Malondialdehyde (MDA)

  After 28 days of treatment

• Total Antioxidant Capacity (TAC)

  After 28 days of treatment

• GSH/GSSG Ratio

  After 28 days of treatment

Study Arms (2)

Sulforaphane tablets

EXPERIMENTAL

People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.

Dietary Supplement: Generally Recognized as Safe - Sulforaphane

Placebo tablets

PLACEBO COMPARATOR

People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.

Dietary Supplement: Placebo

Interventions

Generally Recognized as Safe - Sulforaphane DIETARY_SUPPLEMENT

Participants will be asked to maintain the same food ingestion habits as before the study and take 2 tablets of Sulforaphane a day with a meal for 28 days.

Also known as: Avmacol

Sulforaphane tablets

Placebo DIETARY_SUPPLEMENT

Participants will be asked to maintain the same food ingestion habits as before the study and take 2 tablets of placebo a day with a meal for 28 days.

Also known as: Inactive tablets

Placebo tablets

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥ 50 years of age at enrollment.
• Consume at least 8 alcoholic drinks/week. AUDIT-C score \>8.

You may not qualify if:

• 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 use or unscheduled healthcare visit - for illness).
• Acute alcohol intoxication upon arrival on the day of study visit.
• Any health issue that, the study investigator's judgement, confers excess risk for participation.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Louisiana Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Alcoholism; Inflammation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aline Zaparte
• Organization: LSUHSC

azapar@lsuhsc.edu

504-568-3431

Study Officials

• Aline Zaparte, PhD

  Postdoctoral Fellow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Labels of the product will be replaced with "Tablets A" and "Tablets B" labels.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 15, 2023
• Study Start: January 23, 2024
• Primary Completion: December 8, 2024
• Study Completion: September 1, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)