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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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).
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broccoli Extract Supplementation and Gastrointestinal Health in Older Adults With Active Alcohol Use and Low Diet Quality
- ClinicalTrials.gov ID
- NCT05902754
- Acronym / sponsor ID
- 1268
- Conditions
- Alcohol Use Disorder
- Keywords
- Inflammation, Leaky gut, Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane tablets | Experimental | Dietary Supplement: Generally Recognized as Safe - SulforaphanePeople in the experimental group will be advised to take 2 tablets a day with a meal for 28 days. |
| Placebo tablets | Placebo comparator | Dietary Supplement: PlaceboPeople in the placebo group will be advised to take 2 tablets a day with a meal for 28 days. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects ≥ 50 years of age at enrollment.
- Consume at least 8 alcoholic drinks/week. AUDIT-C score >8.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generally Recognized as Safe - SulforaphaneAlso: AvmacolParticipants 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. | Dietary supplement | Sulforaphane tablets |
| PlaceboAlso: Inactive tabletsParticipants 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. | Dietary supplement | Placebo tablets |
Primary outcome
Gut Leak
Time frame: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
1 secondary outcome
Biomarkers of Inflammation
Time frame: After 28 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline Zaparte, PhD principal investigator
Postdoctoral Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Leak (time frame: Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.