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NCT05902754 · ClinicalTrials.gov registry record · NA
Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder
A NA study of Alcohol Use Disorder, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05902754: Active NA study of Alcohol Use Disorder, sponsored by Louisiana State University Health Sciences Center in New Orleans.
NCT05902754 is a NA study of Alcohol Use Disorder that is active but no longer recruiting, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 40 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05902754, a NA study of Alcohol Use Disorder, is active but no longer recruiting, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 i
Primary Outcome
Measured by serum levels of intestine fatty acid biding proteins and LPS biding protein.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Generally Recognized as Safe - Sulforaphane
Study Locations (1)
Louisiana
- Louisiana Health Sciences Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2025-07-01 |
| Phase | NA |
What the registry record for NCT05902754 still lists
NCT05902754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05902754 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT05902754 about?
NCT05902754 is a clinical study titled "Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder". 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 g...
What is the current status of trial NCT05902754?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-01-23. Estimated completion is 2025-07-01.
What conditions does trial NCT05902754 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT05902754?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Generally Recognized as Safe - Sulforaphane (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05902754?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05902754 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05902754's enrollment target sits among peer trials
40 138th of 184 higher than 40 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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