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Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Generally Recognized as Safe - Sulforaphane
Placebo
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Inflammation, Leaky gut, Supplements

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sulforaphane tablets

    Placebo tablets

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change on the Leaky gut biomarker
    Measured by serum levels of intestine acid biding proteins.
    Change of Inflammation biomarkers
    Measured by serum Interleukin-6 level.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2023
    Last Updated
    October 2, 2023
    Sponsor
    Louisiana State University Health Sciences Center in New Orleans
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05902754
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Louisiana State University Health Sciences Center in New Orleans
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder
    Keywords
    Inflammation, Leaky gut, Supplements

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Labels of the product will be replaced with "Tablets A" and "Tablets B" labels.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sulforaphane tablets
    Arm Type
    Experimental
    Arm Description
    People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days.
    Arm Title
    Placebo tablets
    Arm Type
    Placebo Comparator
    Arm Description
    People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Generally Recognized as Safe - Sulforaphane
    Other Intervention Name(s)
    Avmacol
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Inactive tablets
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change on the Leaky gut biomarker
    Description
    Measured by serum levels of intestine acid biding proteins.
    Time Frame
    Change in serum levels of intestine acid biding proteins after 28 days of intervention.
    Title
    Change of Inflammation biomarkers
    Description
    Measured by serum Interleukin-6 level.
    Time Frame
    Change in serum Interleukin-6 levels after 28 days of intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aline Zaparte, PhD
    Phone
    5045683431
    Email
    azapar@lsuhsc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aline Zaparte, PhD
    Organizational Affiliation
    Postdoctoral Fellow
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder

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