Alcohol Use DisorderNCT05902754
Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder
A study testing Generally Recognized as Safe - Sulforaphane in people with Alcohol Use Disorder, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Generally Recognized as Safe - Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2024to 1 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects ≥ 50 years of age at enrollment.
- Consume at least 8 alcoholic drinks/week. AUDIT-C score >8.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana Health Sciences Center
New Orleans, Louisiana, 70112
About this study
Official title: Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality
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
- Being tested
- Generally Recognized as Safe - Sulforaphane, Placebo
- Keywords
- Inflammation, Leaky gut, Supplements
- Medical subject headings
- Alcoholism, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generally Recognized as Safe - SulforaphaneDietary supplement
Also called Avmacol
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.
PlaceboDietary supplement
Also called Inactive tablets
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.
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane tablets | Experimental | People in the experimental group will be advised to take 2 tablets a day with a meal for 28 days. Receives: Dietary Supplement: Generally Recognized as Safe - Sulforaphane |
| Placebo tablets | Placebo comparator | People in the placebo group will be advised to take 2 tablets a day with a meal for 28 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Leak
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
Measured: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.
Secondary outcomes (1)
Biomarkers of Inflammation
Interleukin-6 (IL-6) and Interleukin-1 beta (IL-1β) are proteins in the blood that help control the body's immune and inflammatory responses. They are released when the body is reacting to stress, infection, or injury. Higher levels of these markers generally indicate increased inflammation in the body and are commonly used to assess overall immune system activity.
Measured: After 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start23 Jan 2024
- Primary completion8 Dec 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Zaparte, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Aline Zaparte, PhD, Principal investigator, Postdoctoral Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902754
- Sponsor's protocol ID
- 1268
- Other IDs
- U24DK132740
- Status last verified
- Apr 2026
- First submitted
- 25 May 2023
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No