Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

Sponsor
Louisiana State University Health Sciences Center in New Orleans (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05902754
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
40
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Generally Recognized as Safe - Sulforaphane
  • Dietary Supplement: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Labels of the product will be replaced with "Tablets A" and "Tablets B" labels.
Primary Purpose:
Basic Science
Official Title:
Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sulforaphane tablets

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

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.
Other Names:
  • Avmacol
  • Placebo Comparator: Placebo tablets

    People in the placebo group will be advised to take 2 tablets 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.
    Other Names:
  • Inactive tablets
  • Outcome Measures

    Primary Outcome Measures

    1. Change on the Leaky gut biomarker [Change in serum levels of intestine acid biding proteins after 28 days of intervention.]

      Measured by serum levels of intestine acid biding proteins.

    2. Change of Inflammation biomarkers [Change in serum Interleukin-6 levels after 28 days of intervention.]

      Measured by serum Interleukin-6 level.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Subjects ≥ 50 years of age at enrollment.

    • Healthy Eating Index (HEI) score below 51 (poor diet).

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Aline Zaparte, PhD, Postdoctoral Fellow

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aline Zaparte, Principal Investigator, Louisiana State University Health Sciences Center in New Orleans
    ClinicalTrials.gov Identifier:
    NCT05902754
    Other Study ID Numbers:
    • 1268
    • U24DK132740
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aline Zaparte, Principal Investigator, Louisiana State University Health Sciences Center in New Orleans
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2023