An interventional study of Generally Recognized as Safe - Sulforaphane and Placebo in Alcohol Use Disorder, sponsored by Louisiana State University Health Sciences Center in New Orleans. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Not applicable, Interventional, and Basic science
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 40 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Additional exclusion criteria:
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
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 Sulforaphane a day with a meal for 28 days.
Also known as: Avmacol
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
Gut Leak
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
Time frame: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.
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.
Time frame: After 28 days of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: After 28 days of treatment
Participants were recruited through the distribution of flyers.
| Milestone | Active Compound Group | Placebo Group |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 19 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
| ng/mL | Sulforaphane Tablets | Placebo Tablets |
|---|---|---|
| Intestinal Fatty Acid Biding Protein - iFABP | 2.60 ± 1.05 | 3.23 ± 1.80 |
| LPS Biding Protein | 26.75 ± 6.33 | 28.57 ± 6.30 |
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.
| pg/mL | Sulforaphane Tablets | Placebo Tablets |
|---|---|---|
| Interleukin-6 (IL-6) | 3.40 ± 1.79 | 3.68 ± 2.78 |
| Interleukin-1 beta (IL-1β) | 6.94 ± 0.62 | 6.95 ± 0.91 |
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.
| μg/mL | Sulforaphane Tablets | Placebo Tablets |
|---|---|---|
| Oxidative Stress Markers - Malondialdehyde (MDA) | 0.245 ± 0.165 | 0.209 ± 0.156 |
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.
| mM | Sulforaphane Tablets | Placebo Tablets |
|---|---|---|
| Total Antioxidant Capacity (TAC) | 85.28 ± 17.4 | 82.80 ± 12.97 |
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.
| Ratio | Sulforaphane Tablets | Placebo Tablets |
|---|---|---|
| GSH/GSSG Ratio | 0.69 ± 0.21 | 0.56 ± 0.15 |
Collected over Weekly follow-ups up from enrollment up to 28 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sulforaphane Tablets | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Placebo Tablets | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(Years) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Mean | 58.7 ± 7.2 | 62.3 ± 6.2 | 60.23 ± 6.05 |
| Sex: Female, Male(Participants) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 11 | 12 | 23 |
| Race (NIH/OMB)(Participants) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 14 | 14 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Intestine Acid Fatty Biding Protein(μg/mL) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Mean | 2.66 ± 1.46 | 2.86 ± 1.23 | 2.76 ± 1.35 |
| LPS Biding Protein(µg/mL) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Mean | 29.45 ± 5.59 | 27.33 ± 8.28 | 28.39 ± 7.05 |
| Malondialdehyde (MDA)(µM/mL) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Mean | 0.200 ± 0.120 | 0.183 ± 0.130 | 0.191 ± 0.125 |
| Total Antioxidant Capacity (TAC)(µM) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Mean | 75.92 ± 9.79 | 80.05 ± 16.79 | 78.02 ± 13.80 |
| GSH/GSSG redox ratio(Ratio) | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|
| Mean | 0.54 ± 0.20 | 0.57 ± 0.16 | 0.56 ± 0.18 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Louisiana State University Health Sciences Center in New Orleans