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Completed

NCT Number: NCT05902754

Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana Health Sciences Center

New Orleans, Louisiana, 70112, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Avmacol

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.

Other names: Inactive tablets

Primary outcomes

  1. Gut Leak

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

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

Secondary outcomes

  1. Biomarkers of Inflammation

    Time frame: After 28 days of treatment

    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.

Other outcomes

  1. Oxidative Stress Markers - Malondialdehyde (MDA)

    Time frame: After 28 days of treatment

    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.

  2. Total Antioxidant Capacity (TAC)

    Time frame: After 28 days of treatment

    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.

  3. GSH/GSSG Ratio

    Time frame: After 28 days of treatment

    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.

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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