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 Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans (NCT01727895), a randomized na study. The primary outcome is Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01727895 |
| Phase | NA |
| Condition | Immunologic Deficiency Syndromes |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Radboud University Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists 15 participants and the condition Immunologic Deficiency Syndromes. It does not describe the enrolled participants’ age, sex, baseline immune status, eligibility criteria, or other characteristics. The population represented by the results therefore cannot be characterized in more detail from the registry record.
Intervention
The intervention was a commercially available beta-glucan derived from baker’s yeast, identified as Glucan #300®. The registry describes two capsules of 500mg daily for seven days. It does not report adherence or whether participants received all planned doses.
Comparator
A control group is included in the posted results, with five participants. Its intervention description is empty. The registry identifies random allocation, but does not explain the control condition or how allocation was carried out.
Primary question
The primary objective was to evaluate systemic effects of oral beta-glucan on innate immune responses. The primary outcome was TNF-α secretion by peripheral blood mononuclear cells stimulated ex vivo with lipopolysaccharide, measured in pg/ml over a timeframe of up to 21 days. The posted results give group medians and inter-quartile ranges, but no statistical test or estimate of a between-group effect.
3. Trial Design
The registry describes a randomized study with no masking and a single-group model. At the same time, the posted primary outcome results are presented for a beta-glucan group and a control group. The registry record does not explain this difference between the stated model and the two groups in the results. It also does not describe the control condition, because the control group’s intervention description is empty.
The study is identified as a pilot study in its official title. Enrollment was 15. The reported primary outcome groups comprise 10 participants in the beta-glucan group and five in the control group. These group counts are descriptive; the record does not provide further details about participant flow, exclusions, or whether every enrolled participant contributed data to every outcome.
The intervention was two capsules of 500mg of beta-glucan daily for seven days. The registry identifies the product as a dietary supplement derived from baker’s yeast. The registry lists the study as completed. It records a start date of 2013-05 and a primary completion date of 2013-07.
The primary outcome was measured over a timeframe of up to 21 days. The registry lists several secondary outcomes, including cytokine production after stimulation with various agents, beta-glucan absorption into the blood compartment, transcriptional pathways, epigenetic modifications, antifungal activity, and faecal microbiota composition. Results for these secondary outcomes are not given in the posted primary outcome results analyzed. The registry record does not report a detailed protocol, allocation procedure, masking procedures, or the planned statistical analysis.
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: Exclusion of subjects was based on pre-defined exclusion criteria or the unability of subjects to comply with the study time schedule.
Overall Study
| Stage | Beta-glucan | Control Group |
|---|---|---|
| STARTED | 10 | 5 |
| COMPLETED | 10 | 5 |
| NOT COMPLETED | 0 | 0 |
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 | Beta-glucan | Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 5 | 15 | |
| Age, Continuous | years | 20 (19 to 22) | 20 (19 to 24) | 20 (19 to 23) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 10 | 5 | 15 |
| TNF-α Secretion by ex Vivo LPS-Stimulated Peripheral Blood mononuclear cells | pg/ml | 691 (276 to 2649) | 749 (287 to 1160) | 720 (282 to 1905) |
6. Primary Endpoint
The registry lists the primary outcome as Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs), measured over up to 21 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | pg/ml |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is TNF-α secretion by peripheral blood mononuclear cells after ex vivo stimulation with lipopolysaccharide, or LPS. Peripheral blood mononuclear cells are a group of blood immune cells. Ex vivo stimulation means that cells are exposed to a stimulus outside the body, in a laboratory setting. The outcome is recorded as a concentration in pg/ml, with the registry specifying a median and inter-quartile range.
The endpoint was chosen to assess leukocyte responsiveness to an inflammatory stimulus. The registry describes this response as a surrogate marker of the antimicrobial response and places it within the broader objective of evaluating systemic effects on innate immune responses. It is therefore a laboratory measure of cell response, not a direct measure of infection, illness, or clinical benefit.
The stated timeframe is up to 21 days. The registry record does not describe the exact timing of collection within that window, how many measurements were taken, or which measurement contributed to each posted group summary. Those details matter because repeated measurements can require methods that account for within-participant correlation, but the record does not establish whether the posted medians represent one time point or a summary across time.
For the beta-glucan group, the reported median is 691.0 pg/ml, with an inter-quartile range from 276.0 to 2649.0. For the control group, the median is 749.0 pg/ml, with an inter-quartile range from 287.0 to 1160.0. The medians and ranges describe the distributions in the two groups; alone, they do not provide an estimate of the uncertainty in a difference between groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is summarized separately by group. The beta-glucan group has a median TNF-α secretion of 691.0 pg/ml, with an inter-quartile range of 276.0 to 2649.0 pg/ml. The control group has a median of 749.0 pg/ml, with an inter-quartile range of 287.0 to 1160.0 pg/ml. These are descriptive statistics. The registry does not report a formal statistical comparison, confidence interval, or p-value for the primary outcome.
The inter-quartile ranges describe the middle half of each group’s observed values. They give information about the spread of the measurements, but are not confidence intervals for the group medians or for a treatment contrast. The beta-glucan group’s reported range is wider than the control group’s range. With only 10 participants in one group and five in the other, individual observations can have a substantial influence on a median and its spread. The registry record does not provide participant-level measurements, so the shape of either distribution and the influence of individual observations cannot be assessed.
The two medians are numerically close, but that fact alone does not establish whether the groups differ, whether they are similar, or whether any apparent difference is compatible with chance variation. A formal comparison would require a defined estimand and analysis, with uncertainty quantified in a way appropriate to the outcome and design. Neither is reported for this endpoint. The registry also does not say whether the analysis accounted for any baseline values, repeated measurements, or other covariates.
The study is designated as a pilot study, and its enrollment is small. That context makes the reported summaries useful for describing the observed data, but they provide limited precision about the underlying distributions or a group contrast. The registry does not report a sample-size justification or a target effect that the study was designed to detect. A lack of a posted statistical test should not be read as evidence that the groups are equivalent.
The record lists six secondary outcomes in addition to the primary outcome, but does not post their results in the information used for this analysis. It reports zero analyses. As a result, the record does not support conclusions about those secondary measures or about whether their results align with the primary endpoint.
Overall, the posted values describe TNF-α secretion in the two listed groups over the specified timeframe. They do not establish a causal effect of beta-glucan, and the registry record does not provide enough analytical detail to quantify the uncertainty around a between-group effect. The intervention and control descriptions, the single-group model designation, and the two-group results also leave aspects of the study structure unclear.
9. Statistical Methods Explained
The primary outcome is reported as a median and inter-quartile range. These summaries are often used when measurements are skewed or when a few observations may lie far from the center. The median is the midpoint of the ordered observations. The inter-quartile range spans the middle half of the observations, from the lower to the upper quartile. Unlike a mean and standard deviation, these summaries do not assume that the distribution is symmetric. The registry states that the primary outcome’s dispersion measure is the inter-quartile range.
The median and inter-quartile range describe the observed values within each group. They do not directly estimate a difference between groups. A comparison could be framed in different ways, such as a difference in medians or a distributional contrast, and the analysis would need to specify which question it addresses. The registry record does not report such an estimand or a method for estimating it. It also does not report a confidence interval or p-value for the primary outcome.
A confidence interval is a range of values that expresses the statistical uncertainty around an estimate, under a specified analysis and its assumptions. It can help readers judge which effect sizes are compatible with the observed data. A confidence interval for a between-group contrast would answer a different question from the inter-quartile ranges reported for each group. Those group ranges describe individual-level variability; they do not give the precision of the contrast. No confidence interval for a contrast is reported in the registry record.
The registry identifies the study as randomized, which ordinarily means assignment to study groups is determined by a random process. Random allocation can help balance prognostic characteristics on average, but it does not guarantee balance in a small study. The record does not describe the randomization sequence, how allocation was concealed, or the implementation of allocation. It also identifies the model as single group while posting results for beta-glucan and control groups. Without further information, the design and analysis structure cannot be resolved from the registry record.
The registry specifies no masking. Masking is a design feature in which participants, staff, or outcome assessors do not know assigned treatment. The record does not explain which people knew the assigned group or how the outcome measurements were collected and assessed. The endpoint is a laboratory measure, but the record does not describe laboratory procedures or whether those assessing the samples were masked.
The primary endpoint timeframe is up to 21 days. If measurements were taken repeatedly from participants, observations from the same person would generally be correlated rather than independent. General statistical methods for repeated measures account for this within-person dependence, and may also model change over time. The registry does not report the number or timing of measurements, how the posted group summaries were derived, or whether any repeated-measures analysis was performed. The record’s count of zero analyses means no inferential analyses are posted in the outcome information.
Sample-size calculations are planning tools: they describe how many participants might be needed under stated assumptions to detect a specified effect with a chosen error rate and power. They do not describe the statistical power actually achieved after a trial has been completed. The registry record does not report the trial’s own sample-size justification. It also does not provide calculated planning sample sizes for this outcome in the information analyzed. The posted group sizes should therefore be read as the numbers represented in the results, not as evidence of adequate or inadequate power.
General methods for over-dispersed data may be relevant when variation is greater than a chosen probability model expects. Over-dispersion can make standard errors too small if it is ignored, leading to overly narrow intervals or misleading tests. The registry provides medians and inter-quartile ranges rather than a fitted probability model, and it does not report a model-based analysis. The summaries alone do not establish whether the data are over-dispersed under any particular model.
The registry lists several secondary outcomes involving cytokines, absorption measured by ELISA, microarray-based transcriptional pathways, epigenetic modifications, antifungal activity, and faecal microbiota composition. Multiple outcomes can create multiplicity: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Common approaches include adjusting significance thresholds, controlling a family-wise error rate, or controlling a false discovery rate. The registry record does not report a multiplicity strategy, and results for those secondary outcomes are not included in the posted outcome information analyzed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and six secondary outcomes. The secondary outcomes cover cytokine production after ex vivo stimulation, beta-glucan absorption into the blood compartment, transcriptional pathways, epigenetic modifications, antifungal activity, and faecal microbiota composition. The registry record does not report how these outcomes were prioritized for analysis, whether particular comparisons were prespecified, or whether a multiplicity adjustment was planned. Results for the secondary outcomes are not posted in the outcome information analyzed.
Multiplicity matters when several outcomes or comparisons are tested. In general, performing many tests without adjustment can increase the chance of at least one result appearing statistically notable by chance. Whether and how to adjust depends on the inferential goals and the analysis plan. Because the registry record does not report a statistical plan or multiplicity method, it is not possible to assess how the study intended to handle multiple outcomes.
The registry does not describe missing outcome data, participant exclusions, or the analysis population. It does not state whether the reported group counts include every enrolled participant or whether any measurements were unavailable. The posted primary outcome counts are 10 for beta-glucan and five for control, while overall enrollment is 15. No imputation method, complete-case approach, or sensitivity analysis is reported. The extent and handling of missing data are therefore not reported in the registry record.
The record also does not state whether participants were analyzed according to their randomized assignment, whether any participants were excluded after allocation, or how protocol deviations were treated. These details are important for understanding the population represented by an analysis and the interpretation of a randomized comparison. No inferential analyses are posted for the primary outcome.
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 |
|---|---|---|---|
| Beta-glucan | 0 | 10 | 0.0% |
| Control Group | 0 | 5 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Beta-glucan | 1 of 10 |
| Control Group | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Beta-glucan | Control Group |
|---|---|---|---|
| Flare of acne, one week after discontinuation of Beta-glucan intake | Skin and subcutaneous tissue disorders | 1 of 10 | 0 of 5 |
The registry reports serious adverse events for both listed groups. Among 10 participants at risk in the beta-glucan group, zero serious adverse events are reported. Among five participants at risk in the control group, zero serious adverse events are reported. These figures describe the recorded counts in this study; they do not show that the risk of serious events is zero, nor do they establish a safety comparison between groups.
Zero observed events can occur even when an underlying event risk is not zero, particularly in a study with few participants. A safety comparison requires attention to the number of participants observed, the duration and completeness of follow-up, and the way events were collected and classified. The registry record does not report these details, nor does it provide confidence intervals or a statistical comparison for serious adverse events. No serious adverse event terms are listed.
The registry separately reports one other, non-serious adverse event among 10 participants at risk in the beta-glucan group, and zero among five participants at risk in the control group. Death counts are not reported in the registry record. These recorded figures are descriptive and should not be treated as a comprehensive assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The results establish that the registry posted group summaries for TNF-α secretion by ex vivo LPS-stimulated peripheral blood mononuclear cells. The beta-glucan group’s median was 691.0 pg/ml, with an inter-quartile range of 276.0 to 2649.0 pg/ml. The control group’s median was 749.0 pg/ml, with an inter-quartile range of 287.0 to 1160.0 pg/ml. These are observations from the participants included in the posted results.
The summaries do not establish that beta-glucan caused a change in leukocyte function. The registry does not provide an inferential comparison, confidence interval, or p-value for the primary outcome. Nor does it report enough information about the timing and analysis of measurements to determine how the summaries relate to the stated timeframe of up to 21 days. The data therefore do not quantify the magnitude or precision of a treatment effect.
The primary endpoint is a laboratory response to an inflammatory stimulus. It is described in the registry as a surrogate marker of antimicrobial response. A surrogate measure is not the same as a clinical outcome: it does not directly report infections, symptoms, or other health outcomes. The registry record does not report whether changes in this laboratory measure correspond to changes in any patient-centered outcome.
The study is labeled a pilot study and enrolled 15 participants. Its posted group sizes are small, and the registry does not report a sample-size justification. This limits how much can be learned about the variability of the endpoint and the precision of any group contrast. The record’s lack of a reported test should not be interpreted as proof of no difference, just as the descriptive values should not be interpreted as proof of an effect.
The registry includes secondary outcomes and adverse-event counts, but does not post results for the listed secondary measures in the information analyzed. The posted safety counts are also limited to the recorded events and do not constitute a comparative safety analysis. In addition, the registry’s single-group model designation does not readily align with the separate beta-glucan and control results, and the control intervention is not described. These gaps restrict interpretation of the study structure and findings.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between describing measurements and making an inferential comparison. A median and inter-quartile range can convey the center and spread of each group’s observed values. They do not, by themselves, quantify the uncertainty in a contrast between groups. That distinction is especially important in a small pilot study, where a few observations can influence the summaries and uncertainty can be substantial.
It also highlights the role of endpoint choice. The primary outcome is an ex vivo immune-cell response, selected as a surrogate marker for antimicrobial response. Interpreting such a measure requires keeping its laboratory meaning separate from clinical outcomes. A result for a biomarker does not automatically indicate an effect on health outcomes, and the registry does not report clinical outcome results for this study.
The record shows why design and analysis details matter alongside outcome values. It identifies random allocation and a single-group model, while the posted results contain two groups; it leaves the control condition undescribed; and it does not report a statistical analysis for the primary endpoint. Such details determine which comparisons are supported and how precisely they can be interpreted.
Finally, the registry lists multiple secondary outcomes without reporting results or a multiplicity strategy. This makes it difficult to understand the planned scope of inference. Clear reporting of analysis populations, missing data, measurement timing, and statistical methods is important for evaluating both the reliability and the limits of trial findings.
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 registry record leaves several trial-specific details unclear. Although random allocation is reported, the randomization procedure and allocation concealment are not described. The design is labeled single group, yet outcome results are posted for a beta-glucan group and a control group. The control group’s intervention description is empty, so the nature of the comparison cannot be determined from the record.
The participant characteristics and eligibility criteria are not reported. The record gives an overall enrollment of 15 and primary outcome group counts of 10 and five, but does not describe participant flow, exclusions, or the analysis population. It does not state whether all participants completed the intervention or had outcome measurements available. Adherence to the seven-day dosing regimen is also not reported.
The outcome timeframe is up to 21 days, but exact measurement times and the number of measurements are not described. The registry does not explain whether the posted summaries represent a specific time point or a method of summarizing repeated observations. Laboratory methods and assessment procedures are not detailed.
No statistical analysis is posted for the primary outcome, and no effect estimate, confidence interval, or p-value is reported. The registry does not state a sample-size justification or explain how missing data, protocol deviations, or multiple outcomes were to be handled. Results for the listed secondary outcomes are not included in the posted outcome information analyzed. Serious adverse event counts are reported, but duration and completeness of safety follow-up are not described. These omissions limit assessment of the study’s precision, internal validity, and the scope of conclusions supported by the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effects of Orally Administered Beta-glucan on Leukocyte Function in Humans — NCT01727895.
- Registry record last updated 2014-07-31; status last verified 2014-07.
- Results first posted 2014-07-31.
- 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 a completed pilot study of oral beta-glucan, with randomized allocation, no masking, and a single-group model designation. It lists enrollment of 15 and reports primary outcome summaries for a beta-glucan group of 10 and a control group of five. The intervention is described as two capsules of 500mg daily for seven days; the control condition is not described.
The primary outcome is TNF-α secretion by ex vivo LPS-stimulated peripheral blood mononuclear cells, measured in pg/ml over up to 21 days. The beta-glucan group median is 691.0, with an inter-quartile range of 276.0 to 2649.0. The control group median is 749.0, with an inter-quartile range of 287.0 to 1160.0. No inferential comparison is posted. The record also lists six secondary outcomes and reports zero serious adverse events in either group, with one other adverse event in the beta-glucan group and none in control. Important design, analysis, and missing-data details are not reported in the registry record.