Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902754
• Other study ID #: 1268
• Secondary ID: U24DK132740
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: Aline Zaparte, PhD
• Phone: 5045683431
• Email: azapar[@]lsuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Louisiana Health Sciences Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on the Leaky gut biomarker	Measured by serum levels of intestine acid biding proteins.	Change in serum levels of intestine acid biding proteins after 28 days of intervention.
Primary	Change of Inflammation biomarkers	Measured by serum Interleukin-6 level.	Change in serum Interleukin-6 levels after 28 days of intervention.