Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder
NCT05902754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-04-28
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Louisiana State University Health Sciences Center in New Orleans
lead OTHER
Principal Investigators
-
Aline Zaparte, PhD · Postdoctoral Fellow
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-23
- Primary Completion
- 2024-12-08
- Completion
- 2025-09-01
Countries
- United States
Study Locations
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