Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

NCT ID: NCT05902754

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2025-07-01

Brief 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

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Sulforaphane tablets

People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.

Group Type: EXPERIMENTAL

Generally Recognized as Safe - Sulforaphane

Intervention Type: 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.

Placebo tablets

People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Avmacol; Inactive tablets

Eligibility Criteria

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.

• Any health issue that, the study investigator's judgement, confers excess risk for participation.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Aline Zaparte

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aline Zaparte, PhD

Role: PRINCIPAL_INVESTIGATOR

Postdoctoral Fellow

Locations

Louisiana Health Sciences Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

U24DK132740

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1268

Identifier Type: -

Identifier Source: org_study_id