Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype (NCT05314374), a randomized phase 1 study. The primary outcome is Glucagon-Like Peptide-1 (GLP-1).

2. Clinical Question

In plain terms, this page focuses on whether participants in the supplement and placebo groups contributed a GLP-1 blood sample at the stated endpoint. The registry reports 18 participants in the Bile Acid Supplement Group and 17 in the Placebo Group, with all participants in each group counted as having provided a sample. The posted comparison therefore concerns sample availability as recorded, rather than a difference in GLP-1 levels.

The research description also names hormones, cell function and body weight as areas of interest, and the secondary-outcome list includes change in weight. The registry record does not provide a GLP-1 concentration result in this primary outcome entry. Consequently, the endpoint supports an interpretation about recorded blood-sample contribution only. The results should not be read as a direct test of a treatment effect on satiety, GLP-1 concentration or weight.

3. Trial Design

This was a randomized, double-masked, parallel-group phase 1 trial sponsored by Mayo Clinic. The registry lists enrollment of 35 participants and a completed status. The start date was 2023-05-12, and the primary completion date was 2024-03-22. These record details describe the registered trial, but do not by themselves explain how randomization or masking was implemented.

The two posted arms were the Bile Acid Supplement Group and the Placebo Group. Their arm descriptions specify participants with obesity and abnormal satiety phenotype. The supplement arm received ileocolonic-release conjugated bile acid supplements, while the placebo arm received matching placebo. The posted endpoint counts include 18 participants in the supplement arm and 17 in the placebo arm.

The record lists three outcome measures and one secondary outcome, Change in Weight. It reports no analyses in the analyses listing. A count of outcome measures is not a count of statistical tests, and the record does not give enough information to reconstruct the full analysis plan or determine which outcomes were analyzed in detail.

The registry record does not report the sample-size justification, randomization procedure, masking procedures, visit schedule beyond the primary endpoint timeframe, or planned statistical methods. The sample-size section elsewhere on the page is an illustration based on the observed effect and stated assumptions; it is not evidence of the trial’s design justification. The registry record does not report that the trial was designed around that illustration.

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.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Glucagon-Like Peptide-1 (GLP-1), measured over 90 days.

The primary endpoint is titled Glucagon-Like Peptide-1 (GLP-1). Its description defines the result as the number of participants who provided a blood sample for GLP-1, with the timeframe listed as 90 days. The unit is Participants, and the result type is a count of participants. Thus, the posted endpoint records sample contribution rather than the amount of GLP-1 measured in those samples.

Sample-collection information can help readers understand whether a measurement was available for participants at a study timepoint. In general, an endpoint must be interpreted according to what was actually recorded: availability of a specimen is different from a laboratory value, a change from baseline, or a clinical outcome. Here, the registry does not post GLP-1 concentrations, a change in concentration, or a comparison of hormone levels under this endpoint.

The trial description identifies hormones and cell function among its research interests, and the primary endpoint’s subject makes the GLP-1 sample relevant to those interests. But the sample count alone cannot establish what the samples contained or whether hormone levels differed between groups. The endpoint is therefore useful for describing completion of this particular measurement, while leaving the biological result unreported in this entry.

7. Results Posted in the Registry

• Bile Acid Supplement Group: 100.0% (18/18) versus 100.0% (17/17) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.

8. Statistical Interpretation

9. Statistical Methods Explained

General explanation. A binary endpoint assigns each participant to one of two categories for the outcome being analyzed. In this registry entry, the categories are whether a participant provided a GLP-1 blood sample or did not provide one. The posted result is summarized as a count of participants, and the comparison is expressed as a risk difference. This framing is distinct from analyzing the measured GLP-1 concentration as a continuous laboratory outcome.

A risk difference subtracts one group’s event proportion from the other group’s event proportion. The event is sample provision. The registry reports a risk difference of 0.0, with a lower endpoint of 0.0 and an upper endpoint of 0.0. Because the posted counts show that all participants in each arm provided a sample, the comparison is about identical observed sample availability in the two groups. No additional calculation is needed to understand the reported direction or value.

General explanation. A confidence interval describes a range of values compatible with the data under a statistical method and its assumptions. It is not a guarantee that the true value lies within the range, and it does not describe the range of individual participant outcomes. Here, the displayed interval is for the risk difference in sample provision. It should not be applied to a GLP-1 concentration difference, because that is not the posted endpoint result.

A p-value is a measure of how compatible the observed data are with a specified statistical null hypothesis, conditional on the method and assumptions. It is not the probability that the null hypothesis is true, nor a measure of clinical importance. The posted p-value is 1.0. The registry entry does not state the test, its assumptions, or whether it was prespecified; those details are not reported in the registry record. The p-value should therefore be read as a feature of the posted comparison rather than as a complete account of the analysis.

The registry identifies the trial as randomized, double-masked and parallel-group. Those design labels describe the registered design, not the implementation details. For example, the sequence-generation method, allocation concealment, masking procedures, and analysis population are not reported in the registry record. Without those details, readers cannot independently assess those aspects of conduct from this record alone.

The posted result is a count outcome, so a count model could be relevant in other settings, but the registry does not report a count-model analysis. The comparison is presented as a risk difference for a binary event. No model specification, adjustment variables, handling of repeated measures, or covariate strategy is reported in the registry record. These methods should not be inferred from the design label or from the form of the displayed result.

General explanation. Over-dispersion matters when observed variation in count data is greater than a statistical model expects. It can affect uncertainty estimates in models that assume a particular count distribution. That concern does not establish that over-dispersion was present: the primary endpoint is posted as the number of participants contributing a sample, and the registry does not report a count regression model or an over-dispersion assessment.

The sample-size section uses a planning illustration computed from the observed effect, with a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are explicitly illustrative assumptions, not the trial’s own design. The registry record does not report the trial’s sample-size justification. Such participant-per-arm illustrations are planning calculations and should not be described as observed power or as evidence that the completed trial had a particular probability of detecting an effect.

The registry lists three outcome measures, one secondary outcome and zero analyses in the analyses listing. Those listing counts do not provide a complete statistical analysis plan. The exact test behind the primary comparison, treatment of missing data, analysis populations, and any planned multiplicity adjustment are not reported in the registry record. No further method should be attributed to the investigators on the basis of the displayed numbers alone.

10. Confidence Intervals and Precision

The primary comparison has a risk difference of 0.0, and the displayed interval runs from 0.0 to 0.0. The point estimate describes no observed difference in sample provision between the arms. The interval is also specific to this binary endpoint; it does not quantify uncertainty about GLP-1 concentrations or any other outcome.

In general, confidence intervals communicate uncertainty around an estimate. A narrow interval can indicate greater precision for the quantity being estimated, whereas a wide interval can leave a broader range of values compatible with the data. Interpreting an interval also requires knowing how it was constructed and whether its assumptions are appropriate. The registry record does not report the interval method for this comparison, so the posted bounds should be presented as reported without assigning an unreported method to them.

In this result, every participant in both groups is recorded as having provided a sample. That complete observed sample-contribution pattern explains why the posted proportions and risk difference coincide, but it should not be generalized to outcomes that were not posted. In particular, the displayed interval does not establish precision for a hormone-level effect, weight change, or satiety measure.

The interval’s endpoints coincide at 0.0 as posted. The registry does not explain how that interval was calculated or why it has those bounds. Readers should not substitute a different interval method or infer a broader analysis from the displayed values. The count and comparison tables and plot on the page present the same endpoint information in complementary forms.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and one secondary outcome, Change in Weight. It also reports zero analyses in the analyses listing. These entries do not reveal how many statistical tests were conducted, which outcomes were treated as confirmatory, or whether any adjustment for multiple comparisons was planned or used. Multiplicity methods are not reported in the registry record.

When a study examines several outcomes or several comparisons, the chance of at least one apparently unusual result can change if each test is interpreted separately. General strategies include prespecifying a primary outcome, defining a hierarchy, or adjusting inference across a family of tests. This general issue cannot be mapped to the trial’s actual analysis without a reported analysis plan. The registry identifies a primary GLP-1 endpoint, but does not describe a multiplicity procedure.

The primary outcome description is a count of participants who provided a blood sample. The posted counts show sample provision for all participants represented in both arms. This does not establish that all participants had complete data for every other outcome, nor does it show how missing measurements were handled in any analysis. Missing-data rules, imputation, exclusions, and analysis populations are not reported in the registry record.

The record does not provide enough information to determine whether all randomized participants were analyzed, whether analyses followed intention-to-treat principles, or whether any per-protocol or safety population was used. Those labels should not be inferred from enrollment, arm counts or the posted primary endpoint. The result can be interpreted as the registry’s posted comparison for sample provision, while broader claims about completeness and analysis populations remain unresolved.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The posted serious adverse event figures are zero in the Bile Acid Supplement Group, among 18 participants at risk, and zero in the Placebo Group, among 17 participants at risk. The record also reports zero deaths in each group. These counts describe the serious-event and death entries shown; they do not establish that no other adverse experiences occurred.

The separate “other” adverse-event counts are 14 among 18 participants at risk in the supplement group and 3 among 17 at risk in the placebo group. These are participant counts in the posted category. The registry entries do not provide the event terms, timing, severity, relatedness assessments, or a detailed account of how this category was defined. The top serious-event terms list is empty.

Safety counts should be read descriptively and in the context of the record’s reporting. A zero serious-event count does not prove absence of risk, and a difference in counts alone does not establish a cause. The registry record does not report additional detail that would support further interpretation of the adverse-event categories.

13. What the Result Does, and Does Not, Mean

The result establishes a narrow descriptive point: the registry records a GLP-1 blood sample for every participant represented in each arm at the 90-day endpoint. The reported risk difference is 0.0, its interval is 0.0 to 0.0, and the p-value is 1.0. The comparison therefore does not show a difference in the recorded sample-provision outcome.

That is not the same as showing that the supplement and placebo produced the same GLP-1 levels. The endpoint is a count of participants who provided a sample, not the result of laboratory testing. The record does not report the measured concentrations or a between-group comparison of those concentrations in this primary result.

Nor does this endpoint answer whether satiety, entero-endocrine cell function or body weight changed. The study description names those areas, and the secondary-outcome list names change in weight, but the relevant results are not included in the registry record. The record’s stated purpose and the outcomes actually posted must be kept separate.

The completed status and arm counts describe the trial record, but do not supply missing methodological details. The registry does not report the sample-size justification, analysis populations, missing-data approach, or the statistical test underlying the displayed comparison. Those omissions limit what can be concluded about broader analyses and precision.

Accordingly, the posted outcome is best read as evidence that sample collection was recorded in both groups, with no observed between-group difference in that binary result. It is not evidence for or against a biological or clinical effect. Any interpretation beyond sample provision would require results and analysis details not reported in the registry record.

14. Why This Trial Matters Statistically

This trial illustrates why endpoint wording matters. A title referring to GLP-1 may suggest a hormone-level result, but the primary outcome description and unit make clear that the posted measure is the number of participants who provided a blood sample. Distinguishing specimen availability from the assay result prevents a sample-completion comparison from being mistaken for a biological response comparison.

It also demonstrates how a risk difference and its interval must be tied to the event actually analyzed. Here, the event is sample provision, and the displayed result is 0.0 with an interval from 0.0 to 0.0. Those values do not transfer to the trial’s other stated interests. A statistical summary has meaning only in relation to its defined outcome and the analysis that produced it.

The registry entry also shows why design labels are not substitutes for a statistical analysis plan. Randomized, double-masked and parallel-group describe design features, while important details about analysis, missing data and multiplicity remain unreported. Statistical readers need both the numerical result and a transparent account of how it was generated.

Finally, planning illustrations should be distinguished from trial planning. An illustration based on the observed effect can help show how assumptions affect hypothetical sample-size planning, but it cannot retrospectively justify the study’s enrollment or serve as observed power. The registry record does not report the trial’s own sample-size rationale.

15. 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 primary result is limited to sample contribution. Although the endpoint is titled GLP-1, the posted outcome is not a GLP-1 concentration, a change in concentration, or a comparison of laboratory values. No such values are reported in the registry record.

The registry’s primary completion timeframe is 90 days, but the record does not give additional detail about the timing of sample collection, baseline measurements, or the laboratory assay in this outcome entry. It also does not report the method used to generate the risk difference interval and p-value.

The record identifies a randomized, double-masked, parallel-group design, but does not describe the allocation sequence, concealment, or masking procedures. The sample-size justification, analysis population, missing-data strategy and multiplicity handling are also not reported in the registry record. These gaps restrict assessment of the analysis and its assumptions.

Only one secondary outcome is named in the registry record, Change in Weight, and no result for it is included. The registry reports three outcome measures overall but does not provide enough information in this record summary to describe all their results. The conditions list includes Healthy, while the two arm descriptions refer to participants with obesity and abnormal satiety phenotype; the record does not clarify this listing further.

Finally, adverse-event information is presented as counts with limited category detail. The registry entries do not give event terms for the “other” category or additional context for the serious-event entries. These limitations mean the page can describe the posted counts but cannot extend them into a broader assessment of biological outcomes, study conduct or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype — NCT05314374.
• Registry record last updated 2025-05-04; status last verified 2025-04.
• Results first posted 2025-05-04.
• 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.

19. Record Summary

The registry record describes NCT05314374, a completed phase 1 randomized, double-masked, parallel-group trial sponsored by Mayo Clinic. Enrollment was 35. The listed study dates are 2023-05-12 for start and 2024-03-22 for primary completion.

The two arms compared an ileocolonic-release conjugated bile acid supplement with matching placebo in participants described as having obesity and abnormal satiety phenotype. The primary outcome was the count of participants providing a GLP-1 blood sample at 90 days.

The posted counts were 18 participants in the supplement arm and 17 in the placebo arm, with sample provision recorded for all participants in each group. The reported risk difference was 0.0, with an interval from 0.0 to 0.0, and p = 1.0. This describes sample contribution, not GLP-1 concentration or a clinical effect. The record lists Change in Weight as a secondary outcome, but its result is not reported in the registry record.