Broccoli Extract for Alcoholism
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used chronic anti-inflammatory drugs or antibiotics in the last 7 days.
What data supports the effectiveness of the treatment Broccoli Extract Supplementation for alcoholism?
Is broccoli extract safe for humans?
How does broccoli extract supplementation differ from other treatments for alcoholism?
Broccoli extract supplementation is unique because it contains sulforaphane, which may help protect the liver from alcohol-induced damage by reducing oxidative stress (damage caused by free radicals) and endoplasmic reticulum stress (a type of cellular stress). This approach is different from traditional treatments that focus on psychological support and nutritional therapy.68111213
What is the purpose of this trial?
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.
Research Team
Aline Zaparte, PhD
Principal Investigator
Postdoctoral Fellow
Eligibility Criteria
This trial is for adults over 50 who have a poor diet (HEI score below 51) and consume at least 8 alcoholic drinks per week, with an AUDIT-C score greater than 8. It's not suitable for those who don't meet these specific alcohol and dietary criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sulforaphane or placebo tablets, taking 2 tablets a day with a meal for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Broccoli Extract Supplementation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Louisiana State University Health Sciences Center in New Orleans
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator