Clinical trial NCT05902754: Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder
Official title: Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Inflammation
Leaky gut
Supplements
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Additional exclusion criteria:

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

Primary outcomes:
measure: Change on the Leaky gut biomarker
timeFrame: Change in serum levels of intestine acid biding proteins after 28 days of intervention.
measure: Change of Inflammation biomarkers
timeFrame: Change in serum Interleukin-6 levels after 28 days of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana Health Sciences Center
state: Louisiana
Study officials:
affiliation: Postdoctoral Fellow
name: Aline Zaparte, PhD
role: PRINCIPAL_INVESTIGATOR
References: