Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Dietary supplement: Generally Recognized as Safe - Sulforaphane; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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 use or 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sulforaphane tablets; 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; 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.; Other Names: Avmacol
Placebo Comparator: Placebo tablets; People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.	Dietary supplement: Placebo; 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.; Other Names: Inactive tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of Inflammation	Interleukin-6 (IL-6) and Interleukin-1 beta (IL-1β) are proteins in the blood that help control the body's immune and inflammatory responses. They are released when the body is reacting to stress, infection, or injury. Higher levels of these markers generally indicate increased inflammation in the body and are commonly used to assess overall immune system activity.	After 28 days of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative Stress Markers - Malondialdehyde (MDA)	Oxidative stress occurs when there is an imbalance between harmful molecules (free radicals) and the body's ability to neutralize them. Malondialdehyde (MDA) is a byproduct of cell damage caused by oxidative stress, so higher levels indicate increased damage.	After 28 days of treatment
Total Antioxidant Capacity (TAC)	Total Antioxidant Capacity (TAC) reflects the combined ability of all antioxidants in the blood (such as vitamins, proteins, and enzymes) to neutralize these harmful molecules, providing an overall measure of the body's defense system rather than a single antioxidant.	After 28 days of treatment
GSH/GSSG Ratio	GSH (reduced glutathione) is an active antioxidant that helps protect cells from damage, while GSSG (oxidized glutathione) is the form it becomes after neutralizing harmful molecules. The GSH/GSSG ratio shows the balance between these two forms, with lower ratios generally indicating higher oxidative stress and reduced antioxidant protection.	After 28 days of treatment

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Aline Zaparte, PhD, Postdoctoral Fellow

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Actual): December 8, 2024
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Leaky gut; Supplements
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Pathological Conditions, Signs and Symptoms; Alcoholism; Inflammation; Antineoplastic Agents; Physiological Effects of Drugs; Protective Agents; Anticarcinogenic Agents; Sulforaphane
• Other Study ID Numbers: 1268; U24DK132740 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No