This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder (NCT05902754), a randomized na study. The primary outcome is Gut Leak.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05902754 |
| Phase | NA |
| Condition | Alcohol Use Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Louisiana State University Health Sciences Center in New Orleans |
| Results posted | Yes |
2. Clinical Question
Population
The registry title describes older adults with active alcohol use and low diet quality; the listed condition is Alcohol Use Disorder. The record lists enrollment as 40. Further eligibility details, including the age range and the criteria used to define low diet quality or active alcohol use, are not reported in the registry record.
Intervention
The experimental intervention is sulforaphane tablets, described in the registry as a dietary supplement. Participants in that group were advised to take 2 tablets a day with a meal for 28 days. The study description discusses broccoli sprouts extract as a source of sulforaphane, but the intervention name in the arms is sulforaphane tablets.
Comparator
The comparator is placebo tablets. Participants in the placebo group were also advised to take 2 tablets a day with a meal for 28 days. The record does not describe the tablets’ appearance, ingredients, or how adherence to the advice was assessed.
Primary question
The primary outcome is titled Gut Leak. It concerns serum concentrations of intestinal fatty acid-binding protein and lipopolysaccharide-binding protein at 28 days. The clinical question is whether the reported marker measurements differ between the sulforaphane and placebo groups at that time. A numerical comparison and its uncertainty are not reported in the registry record, so the posted information does not establish the direction or precision of any group difference.
3. Trial Design
This is a randomized, triple-masked, parallel-group trial. Randomization means participants are assigned to study groups by a random process; a parallel-group design means the groups receive their assigned interventions over the same study period rather than crossing over between interventions. The registry labels masking as triple, but does not identify which parties were masked or describe how masking was maintained.
The registry lists two arms: sulforaphane tablets and placebo tablets. Participants in each arm were advised to take 2 tablets a day with a meal for 28 days. No further details about the supplement formulation, placebo composition, adherence measurement, or other care during the study are reported in the registry record. The phase is listed as NA.
The official title describes the study as evaluating broccoli extract supplementation and gastrointestinal health in older adults with active alcohol use and low diet quality. Alcohol Use Disorder is the listed condition. The record lists enrollment as 40 and identifies Louisiana State University Health Sciences Center in New Orleans as the sponsor. The study is marked completed, with a start date of 2024-01-23 and a primary completion date of 2024-12-08.
These design labels describe the planned comparison, not the results. They do not by themselves show whether the groups remained comparable, whether participants followed the advice, or whether the interventions affected the outcome. Those details, along with a participant flow account and the final analysis populations, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: No participants were excluded before assignment. 40 participants initiated the study but only 38 completed the study.
Overall Study
| Stage | Active Compound Group | Placebo Group |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 19 | 19 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Active Compound Group | Placebo Group |
|---|---|---|
| Physician Decision | 1 | 0 |
| Lost to Follow-up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intestinal fatty acid-binding protein (iFABP) and lipopolysaccharide-binding protein (LBP) are blood markers used to assess gut health and inflammation. iFABP is released into the bloodstream when cells lining the intestine are damaged, so higher levels may indicate injury to the gut lining. LBP is a protein that binds to bacterial components from the gut (called lipopolysaccharides), and higher levels may reflect increased exposure of the body to these bacterial products.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Sulforaphane Tablets | Placebo Tablets | Total |
|---|---|---|---|---|
| Participants analysed | 19 | 19 | 38 | |
| Age, Continuous | Years | 58.7 (SD 7.2) | 62.3 (SD 6.2) | 60.23 (SD 6.05) |
| Sex: Female, Male: Female | Participants | 8 | 7 | 15 |
| Sex: Female, Male: Male | Participants | 11 | 12 | 23 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 4 | 5 | 9 |
| Race (NIH/OMB): White | Participants | 14 | 14 | 28 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Intestine Acid Fatty Biding Protein | μg/mL | 2.66 (SD 1.46) | 2.86 (SD 1.23) | 2.76 (SD 1.35) |
| LPS Biding Protein | µg/mL | 29.45 (SD 5.59) | 27.33 (SD 8.28) | 28.39 (SD 7.05) |
| Malondialdehyde (MDA) | µM/mL | 0.200 (SD 0.120) | 0.183 (SD 0.130) | 0.191 (SD 0.125) |
| Total Antioxidant Capacity (TAC) | µM | 75.92 (SD 9.79) | 80.05 (SD 16.79) | 78.02 (SD 13.80) |
| GSH/GSSG redox ratio | Ratio | 0.54 (SD 0.20) | 0.57 (SD 0.16) | 0.56 (SD 0.18) |
| Interleukin-6 | pg/mL | 4.61 (SD 2.90) | 4.08 (SD 2.80) | 4.34 (SD 2.80) |
| Interleukin-1 beta (IL-1β) | pg/mL | 6.97 (SD 0.77) | 7.09 (SD 0.63) | 7.03 (SD 0.70) |
6. Primary Endpoint
The registry lists the primary outcome as Gut Leak, measured over Serum concentration of intestinal fatty acid-binding protein and LPS biding protein at 28 days..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/mL |
| Endpoint classification | Continuous Endpoint |
The primary outcome is titled Gut Leak and is described as serum concentration of intestinal fatty acid-binding protein and lipopolysaccharide-binding protein at 28 days. The measurement unit is ng/mL, and the outcome is specified as a mean with standard deviation. The registry description also refers to intestine fatty acid-binding proteins and LPS binding protein. It does not provide a numerical result for either marker or a group comparison.
The registry characterizes iFABP and LBP as blood markers used to assess gut health and inflammation. It states that iFABP is released into the bloodstream when cells lining the intestine are damaged, so higher levels may indicate injury to the gut lining. The description of LBP is incomplete in the registry record; further interpretation of that marker is therefore not available from the posted information.
In general, biomarker measurements can provide an indication of biological processes, but a marker is not itself a direct measurement of every aspect of gut function or a clinical health outcome. Interpretation depends on the marker’s measurement properties, timing, variability, and the analysis used. The registry names more than one marker in the primary outcome and indicates several categories or time points; it does not reduce these to a single reported comparison. The endpoint’s numerical findings and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the study question and the planned endpoint, but it does not report a numerical primary-outcome result. It is therefore not possible to describe the observed mean levels of iFABP or LBP, the direction or size of any difference between groups, or the precision of an estimated contrast. No conclusion about the measured endpoint can be drawn from the design information alone.
The outcome is specified as a mean with standard deviation. In general, the mean describes the average measurement in a group, while the standard deviation describes variability among measurements. Neither statistic is a treatment contrast: assessing a randomized comparison ordinarily requires reporting how the groups compare, along with a measure of uncertainty. The record does not provide that comparison or a confidence interval. A confidence interval, in general, communicates a range of values compatible with the data and the analysis assumptions; without one, the precision of a group contrast cannot be assessed.
The registry identifies the measurement time as 28 days, after participants were advised to take their assigned tablets for 28 days. The time point and advice do not establish what participants actually took or whether the measurements changed from baseline. Baseline values, adherence results, and change-from-baseline analyses are not reported in the registry record.
The posted information lists 5 outcome measures and a secondary outcome concerning biomarkers of inflammation. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. The record lists 0 analyses. Without the outcome-specific estimates, analysis methods, and any prespecified approach to selecting among measures or time points, the statistical evidence for the primary question cannot be evaluated from the registry entry.
Accordingly, the record supports describing the trial’s design and intended biological measurements, not stating whether the groups differed. This distinction matters: an absent or unreported estimate is not evidence that the groups were identical, and it is not evidence that they differed. The status marked completed does not substitute for posted results. Numerical primary findings, their uncertainty, and the details needed to interpret them are not reported in the registry record.
9. Statistical Methods Explained
The statistical details available in the registry record are limited. The trial is randomized and parallel-group, the primary outcome is described as a continuous measure reported as a mean with standard deviation, and the record lists assumptions for planning illustrations. It does not report an outcome analysis or the results needed to reproduce or assess an inferential comparison. The explanations below describe general statistical concepts and distinguish them from the methods documented for this trial.
What does a mean and standard deviation describe?
In general, a mean is a summary of the central level of a continuous measurement. The standard deviation describes how spread out measurements are around that mean. These summaries help characterize a group, but they do not by themselves show whether two groups differ. A comparative analysis needs an estimate of the contrast between groups, together with information about uncertainty. The registry does not report group means, standard deviations, or a contrast for the primary markers.
Why does randomization matter?
In general, random assignment is intended to make the groups comparable at the start of a trial with respect to both measured and unmeasured characteristics, on average. This supports interpreting a between-group contrast as an effect of assignment, subject to the trial’s conduct and analysis assumptions. Randomization does not guarantee that every characteristic will be balanced in a particular trial. Baseline characteristics, allocation procedures, and the analysis approach are not reported in the registry record, so those features cannot be assessed from the available information.
What does a confidence interval add?
In general, a confidence interval expresses statistical uncertainty around an estimate. A narrow interval indicates greater precision than a wide interval, under the assumptions of the method; an interval that includes values in different directions may leave the direction of an effect uncertain. The interval is not a probability statement about a particular fixed effect. Because no primary-outcome estimate or confidence interval is reported, neither the magnitude nor the precision of a group contrast can be described for this study.
What is a significance level?
The registry’s planning assumptions specify a two-sided significance level of 0.05. In general, a significance level is a threshold used in a statistical testing procedure to control the probability of a false positive under a defined null hypothesis and analysis framework. It does not indicate the probability that a finding is true, and it does not measure the size or clinical relevance of an effect. The registry does not report an outcome test, a p-value, or the statistical model used for the primary analysis. The planning threshold should not be mistaken for a reported trial result.
What do the planning assumptions mean?
The record describes planning illustrations based on the observed effect, with equal allocation, a normal approximation, a two-sided significance level of 0.05, and a detectable effect expressed as a stated fraction of the observed effect. It says that the continuous-outcome illustrations are expressed as participants per arm. These are planning assumptions, not evidence about the trial’s observed uncertainty or its design justification. The sample-size justification and any original design calculations are not reported in the registry record. Planning illustrations are not observed power; they cannot replace an estimate and confidence interval for the actual outcome.
In general, sample-size planning depends on assumptions about variability, the effect worth detecting, the significance level, and the allocation. If the effect used for illustration comes from observed results, the illustration is conditional on that observed estimate and should not be treated as an independent confirmation. No numerical planning estimates or numerical observed effects are reported in the registry information available for this analysis.
Why can over-dispersion matter?
In general, over-dispersion means that observed variability is greater than a statistical model assumes. When a model underestimates variability, standard errors can be too small and confidence intervals too narrow, making evidence appear more precise than it is. The relevant issue depends on the outcome type and model. The primary endpoint is described as continuous, but the registry does not specify a model or report an assessment of dispersion. No claim about over-dispersion in this trial can be made from the record.
What is missing from the analysis description?
The registry lists 0 analyses. It does not report how the markers were summarized or compared, whether baseline measurements were incorporated, how missing measurements were handled, or which participants were included in each analysis. The record also indicates that the primary outcome has several categories or time points and is not reduced to a single comparison. In general, the selected analysis can affect the estimate and its uncertainty, so these details are important when interpreting results. They are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures and identifies biomarkers of inflammation as a secondary outcome. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. When several outcomes, markers, or time points are tested, the chance of obtaining at least one apparently unusual result can increase. In general, a prespecified multiplicity strategy can address this issue by controlling error rates or by clearly identifying a primary comparison. The registry record does not report such a strategy, and it does not identify a single numerical primary-outcome comparison.
The record lists 0 analyses. It does not provide an analysis plan describing how the outcome measures were selected, how many comparisons were intended, or whether any adjustment for multiple testing was used. The significance level of 0.05 appears among planning assumptions, but that does not establish how hypothesis tests for the reported outcomes were conducted.
Missing-data handling is not reported in the registry record. There is no posted account of missing measurements, reasons for missingness, imputation, or sensitivity analyses. The record also does not specify the analysis populations, such as whether the primary analysis included all randomized participants or followed another rule. These omissions do not show that data were missing or that a particular population was used; they mean those matters cannot be evaluated from the registry information.
In general, missing-data methods and analysis populations matter because the observed measurements may not represent all randomized participants if availability is related to group assignment or outcome. Without a participant flow account and explicit methods, the extent and possible influence of missing data cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sulforaphane Tablets | 0 | 20 | 0.0% |
| Placebo Tablets | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sulforaphane Tablets | 0 of 20 |
| Placebo Tablets | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sulforaphane Tablets | 0 of 20 |
| Placebo Tablets | 0 of 20 |
The adverse-event entries list Sulforaphane Tablets and Placebo Tablets separately. For each group, the registry reports 20 participants at risk for serious adverse events and 0 participants affected. It also reports 20 at risk for other adverse events and 0 affected, with 0 deaths in each group. These are the counts recorded in the registry; they are not rates or comparative estimates.
A zero recorded count means that the registry entry reports no events in that category for the listed group. It does not establish that an event is impossible, that all potential harms were assessed, or that the treatments have equivalent safety. In general, absence of recorded events can be difficult to interpret without knowing how events were defined, collected, monitored, and reported, and how complete follow-up was.
The registry does not provide serious adverse event terms, as the list of top serious terms is empty. Details such as event definitions, observation periods, severity grading, relatedness assessments, withdrawals due to adverse events, and completeness of safety follow-up are not reported in the registry record. The entries therefore describe what was recorded in the adverse-event fields, while leaving broader safety interpretation limited.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized, triple-masked, parallel-group study comparing sulforaphane tablets with placebo tablets in the context described by its title. It identifies serum iFABP and LBP at 28 days as the primary outcome and records advice to take 2 tablets a day with a meal for 28 days. It also reports adverse-event counts for the two groups.
The record does not report numerical results for the primary markers, a between-group estimate, a confidence interval, or a p-value. It therefore does not show whether either marker was higher or lower in one group, how large any contrast was, or how precisely it was estimated. A completed status is a study-status entry, not a substitute for outcome results. No conclusion about a treatment effect on the primary endpoint follows from the information recorded.
In general, biomarker findings should be interpreted in relation to the measurement, the timing, the analysis, and the clinical question. A change in a biological marker would not automatically establish a change in symptoms, disease course, or other health outcomes. The registry describes iFABP and LBP as markers used to assess gut health and inflammation, but does not provide findings that could be evaluated in this study.
The adverse-event entries record zero affected participants in the listed categories, but those counts alone cannot establish that there is no risk or that the groups have equivalent safety. The entry does not report the event-collection details needed to interpret the completeness or scope of safety reporting.
The most defensible reading is therefore descriptive: the registry records a trial design, intended biomarker measurements, and adverse-event counts, while numerical primary findings and key analysis details are not reported in the registry record. That is different from evidence of no effect, evidence of an effect, or a definitive safety conclusion.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary outcome is described using more than one biological marker and the registry indicates several categories or time points. A clear primary comparison is important when a study can generate multiple related results. Without a reported choice of comparison or a multiplicity plan, readers cannot tell how the primary question was operationalized or how to interpret any selected result. The registry does not provide a numerical primary-outcome analysis.
The study also illustrates the difference between design information and evidence from results. Randomization, masking, a placebo group, and a defined measurement time describe how a comparison was intended to be made. They do not reveal the observed marker levels or the uncertainty around a group contrast. Reporting those estimates is necessary for readers to judge the strength and precision of the evidence.
Planning illustrations can help explain what assumptions a sample-size calculation uses, but they are not a substitute for observed results. The registry’s planning assumptions refer to an effect based on the observed effect, equal allocation, a normal approximation, and a two-sided significance level of 0.05. The record does not report the outcome estimate needed to interpret such planning in relation to the trial’s findings. In general, a planning calculation should not be described as observed power.
Finally, registry outcome reporting is part of statistical transparency. Information about analysis populations, missing data, and multiplicity helps readers distinguish an intended analysis from one selected after results are known. Those methods are not reported in the registry record. This limits what can be learned statistically even though the study status is marked completed.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this specific trial is that the registry record does not report numerical primary-outcome results. It names iFABP and LBP, gives the measurement unit and time point, and describes the outcome as a mean with standard deviation, but does not provide group summaries or an estimated contrast. Precision and direction therefore cannot be assessed.
The primary outcome is described as involving several categories or time points, and the registry does not reduce it to one comparison. The record does not explain which marker or time point was intended to anchor the primary inference, nor does it describe a multiplicity approach. It also lists 0 analyses, leaving the statistical model and testing procedure unreported.
Important details about study conduct are also absent from the registry record. It does not describe eligibility criteria in detail, the masking procedures, adherence, baseline outcome values, participant flow, analysis populations, or missing-data methods. These omissions do not establish that a problem occurred; they restrict assessment of whether and how it could affect interpretation.
The description of LBP is incomplete, so its biological interpretation cannot be expanded from the registry entry alone. The safety entries record zero affected participants in the listed categories, but event definitions and follow-up details are not reported. The record also does not provide a detailed account of the intervention formulation or placebo composition. Together, these limitations mean that the study’s intended comparison is clearer than its reported statistical evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder — NCT05902754.
- Registry record last updated 2026-04-28; status last verified 2026-04.
- Results first posted 2026-04-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT05902754, titled Broccoli Extract Supplementation in Older Adults With Alcohol Use Disorder. Its official title concerns broccoli extract supplementation and gastrointestinal health in older adults with active alcohol use and low diet quality. The study is marked completed, lists enrollment as 40, and identifies Louisiana State University Health Sciences Center in New Orleans as sponsor. The phase is listed as NA.
The design is randomized, triple-masked, and parallel-group. The arms are sulforaphane tablets and placebo tablets, with advice to take 2 tablets a day with a meal for 28 days. The primary outcome is Gut Leak, described as serum iFABP and LBP concentration at 28 days, in ng/mL, with mean and standard deviation specified.
The record lists 5 outcome measures and a secondary outcome concerning biomarkers of inflammation. It does not report a numerical primary-outcome comparison, analysis details, missing-data methods, or analysis populations. Adverse-event entries list zero affected participants and zero deaths in each group.