Pilot Study:Role of Dietary Fiber in PCOS Anovulation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Study:Role of Dietary Fiber in PCOS Anovulation (NCT00703092), a na phase 4 study. The primary outcome is Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety..

2. Clinical Question

In practical terms, the planned question was whether these measurements could be collected and described during a fiber-supplementation study in women with PCOS. The study also listed feasibility topics: enrollment strategies, retention, compliance, participant characteristics, and data-collection challenges. Those topics concern whether a study process can be carried out and what information can be gathered; they are distinct from estimating an intervention effect.

Because enrollment ended early and no assays were run, the registry record does not answer whether ovulation or any other planned measure changed. It also does not establish whether participants took the intervention as intended or completed the planned observation period. The record does not report an untreated, placebo, or active comparator, and no controlled estimate can be drawn from this design.

3. Trial Design

The registry record identifies this as a phase 4, single-group study of Fiber-Stat in women with PCOS. Allocation is listed as NA and masking as NONE. These descriptions fit a study without a randomized group allocation or masking; the record does not describe a control arm. Its design is not a randomized comparison, so differences from a control group cannot be estimated.

The intended intervention was Fiber-Stat at 2 tablespoons daily. The study purpose refers to 6 months of supplementation. The primary outcome description frames the purpose as generating preliminary data at baseline and after 6 months, while the listed primary timeframe is 10 months. The registry record does not explain how these time descriptions relate to each other or provide a schedule of measurements.

Enrollment was 2. The record states that the study was terminated early due to lack of enrollment. It lists a start date of 2008-02 and a primary completion date of 2010-03, and the current status is TERMINATED. It does not describe the reasons for the enrollment difficulty beyond that statement, nor does it provide details of recruitment procedures or participant flow.

The primary outcome description includes ovulation rates, insulin sensitivity, concentrations of circulating androgens, and satiety. A secondary outcome concerns enrollment strategies, retention, compliance, participant characteristics, and data-collection challenges. Although the record lists 2 outcome measures, it reports that no assays were run and there is no data to report. The registry record therefore documents intended design and measurement aims, rather than completed outcome analyses. It does not report a statistical analysis plan, a sample-size justification, or the details of any planned 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.

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 Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety., measured over 10 months.

The primary outcome description is an aim to generate preliminary data on the range of outcome measures at baseline and after 6 months of fiber supplementation. It names ovulation rates, insulin sensitivity, circulating androgen concentrations, and satiety. These are different kinds of measures: ovulation is a reproductive outcome, insulin sensitivity and androgen concentrations are physiological measurements, and satiety concerns appetite-related experience. The registry record does not specify operational definitions, measurement instruments, units, or a particular summary measure for these outcomes.

In general, collecting baseline and follow-up measurements can describe what was observed over time in a group and whether the planned measures can be obtained. Such information can help assess feasibility and inform later research. Without a comparator, however, a change over time cannot be separated from other explanations, including natural variation or changes unrelated to the intervention. That is a general limitation of interpreting an uncontrolled before-and-after design.

The registry record says the study was terminated early due to lack of enrollment and that no assays were run, so there are no primary endpoint values to describe. The primary outcome timeframe is listed as 10 months, while the description refers to a baseline and assessment after 6 months of supplementation. The record does not explain this distinction. It also does not report which planned measures would have been assessed by an assay or how missing measurements would have been handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a single-group study with no masking and allocation listed as NA. It reports no analyses. The following concepts explain how the design and the stated planning assumptions would generally relate to statistical interpretation; they do not imply that these analyses were conducted.

What does a single-group design allow?

In general, a single-group design can describe outcomes within the enrolled group, provided measurements are collected. A baseline and later measurement can show the observed pattern over time. Without a comparison group, that pattern cannot isolate the effect of an intervention from other influences. For example, natural changes, measurement variability, or changes in behavior could coincide with the period of intervention. This is why a within-group difference is not equivalent to a controlled treatment effect.

Here, the registry record reports no assay results and no outcome data. There is consequently no observed baseline-to-follow-up pattern to estimate. The intended baseline and 6-month measurements remain part of the study aim, rather than reported endpoint results. The listed primary timeframe of 10 months is not reconciled with the description of a follow-up after 6 months of supplementation.

What does an estimate and its uncertainty mean?

In general, an estimate is a numerical summary of an outcome or contrast, while a confidence interval describes the range of values compatible with the data under the method's assumptions. A narrow interval generally indicates greater precision than a wide interval, although precision does not establish that a result is unbiased or clinically important. A p-value, when reported, addresses compatibility between data and a specified null model; it is not the probability that a hypothesis is true.

None of these quantities can be interpreted for the planned primary outcomes from this registry record because no assays were run and no data are reported. There is no reported estimate, confidence interval, or outcome p-value to discuss. The record lists 0 analyses. This should be read as absence of reported analysis results, not as a statistical test showing no effect.

Why does the absence of a comparator matter?

Generally, a comparison group helps estimate what might have happened over the same period without the intervention, subject to the design's assumptions and limitations. Randomization can make groups more comparable on average, while masking can reduce some forms of bias in measurement or care. The registry record describes neither randomized allocation nor masking, and it describes a single group. It therefore does not support a randomized or controlled comparison.

Even if baseline and follow-up values had been reported, their interpretation would be descriptive. A before-and-after change in a single group cannot alone show that Fiber-Stat caused the change. In this case, the data needed even for that descriptive account are absent from the record.

How should planning illustrations be understood?

In general, sample-size planning uses assumptions about the effect worth detecting, variability, significance level, allocation, and analysis method. A planning calculation asks how much information a future study might need under those assumptions. It is not a result observed in the current study, and it is not observed power.

The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The assumptions describe a planning illustration, not the registry's single-group design. Since the record reports no observed effect, the illustrations cannot be treated as a data-based account of this trial's results. The registry record does not report a sample-size justification for the actual study.

For time-to-event outcomes, general planning methods may use event counts rather than participant counts; the stated planning note describes total events for that type of illustration and participants per arm for other illustrations. No time-to-event primary endpoint is described in the registry record, and no event-based outcome analysis is reported. These planning conventions do not create trial findings.

Why does small enrollment affect precision?

In general, limited enrollment tends to leave less information for estimating an outcome and can make estimates unstable. It can also make it difficult to characterize variability, assess unusual observations, or describe subgroups. These are general statistical considerations, not calculated properties of this trial. Since no endpoint values are reported, precision cannot be quantified and no confidence interval can be assessed.

The enrollment figure of 2 is not a basis for claiming a particular level of precision or power. The study was terminated for lack of enrollment, and the record states that no assays were run. No observed effect is available to use in a power interpretation. The record also does not report the assumptions that may have guided the original sample-size target or a formal sample-size justification.

What do missing analyses imply?

The record's lack of analysis results means there is no basis for comparing statistical methods or checking whether model assumptions were met. The choice of a model would ordinarily depend on the form of each outcome, repeated measurements, missingness, and the estimand of interest. Those details are not reported in the registry record. It would be inappropriate to infer which method was intended or to reconstruct an analysis plan.

In general, over-dispersion occurs when outcome variability exceeds what a chosen model assumes. A model that ignores this can understate uncertainty. This is a general methodological issue, not a reported issue in this study; no outcome distributions or fitted models are available for evaluation.

Similarly, a recalculation from posted summary statistics would require usable outcome summaries. None are reported. The record does not provide an adjusted analysis, an unadjusted estimate, or a sponsor analysis to compare with a recalculation. No treatment-effect calculation can be recovered from the stated enrollment and design information alone.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome description names ovulation rates, insulin sensitivity, circulating androgen concentrations, and satiety. The record also lists a secondary feasibility outcome concerning enrollment, retention, compliance, participant characteristics, and data-collection challenges. Multiple outcomes can raise multiplicity questions when several statistical tests are performed, because the chance of at least one apparently notable result may change as the number of tests increases. That is a general statistical concern; it does not establish that this study conducted such tests.

The registry record reports 0 analyses and says no assays were run, so there are no outcome tests or results for which an adjustment can be evaluated. It does not report a hierarchy among the named primary measures, a multiplicity adjustment, a prespecified analysis plan, or whether any outcomes were intended to be exploratory beyond the stated preliminary-data aim. These details are not reported in the registry record.

Missing-data handling is also not reported. The study ended early due to lack of enrollment, but the record does not provide participant flow, endpoint completion, reasons for missing measurements, or a missing-data method. Because no assays were run, the available information does not support an assessment of endpoint missingness or a comparison of different approaches to it.

The analysis population is not reported in the registry record. In general, an analysis population specifies which participants contribute to an analysis and under what rules. The recorded enrollment of 2 should not be mistaken for a defined endpoint analysis population when the record says no data are available. No intention-to-treat, per-protocol, or other analysis set is described.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry record lists the Fiber-Stat group as having 2 participants at risk, 0 with serious adverse events, and 0 with other adverse events. Deaths are recorded as null. The registry record does not define the observation period or provide event-level descriptions, so the figures should be read as registry entries rather than as a complete account of all possible safety information.

A zero count means that the registry lists no events in that category; it does not demonstrate that an intervention is safe or exclude uncommon harms. In general, the ability to detect adverse events depends on the amount of exposure, duration and completeness of follow-up, and the method used to collect events. Those details are not reported in the registry record. The study was terminated early due to lack of enrollment, and the record states that no assays were run. It does not explain how safety information was collected or whether the at-risk figure represents all intended follow-up.

Null for deaths is not the same as a reported zero unless the record explicitly gives a zero. The event counts do not permit a comparison with another group because no control group is described. They also cannot be used to establish a rate or comparative risk from the information in the registry record.

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

The record documents an intended pilot investigation of daily Fiber-Stat in women with PCOS. Its stated purpose was to generate preliminary data on ovulation and related measures after 6 months of supplementation, alongside feasibility topics such as enrollment, retention, compliance, participant characteristics, and data collection. The record also reports early termination due to lack of enrollment.

What the result does not provide is an estimate of change in ovulation, insulin sensitivity, androgen concentrations, or satiety. The registry record explicitly says no assays were run and there is no data to report. It does not report effect estimates, uncertainty intervals, or analyses for these outcomes. The absence of reported measurements cannot be interpreted as evidence that outcomes stayed unchanged.

The design also does not provide a control comparison. A single-group study can, in general, describe what happened among participants when measurements are available, but it cannot by itself separate intervention effects from other changes over time. Here, no outcome data are available for even a descriptive comparison of baseline with follow-up.

The enrollment figure and adverse-event entries have limited scope. Enrollment of 2 does not establish endpoint completion, because the record says no assays were run. The registry lists 0 serious and 0 other adverse events among 2 at risk, with deaths listed as null, but the record does not provide enough information about event collection or follow-up to treat these entries as a comprehensive safety assessment.

Accordingly, the statistical meaning is mainly about information that was not generated or reported. The record shows a planned pilot study that stopped early, not a completed test of whether the intervention changes the stated outcomes. The trial cannot support a conclusion about efficacy, lack of efficacy, or comparative safety from the posted data. Any planning illustration based on an observed effect is also not an observed study result, particularly when no endpoint effect is reported.

13. Why This Trial Matters Statistically

This study matters statistically because it illustrates the distinction between a study's intended question and the evidence available to answer it. The registry describes a pilot aim to collect preliminary outcome and feasibility information, but early termination due to lack of enrollment prevented the planned assays. Without measurements, there is no estimate to interpret, no uncertainty to quantify, and no model fit to assess.

Pilot studies can be valuable for identifying practical obstacles and testing whether measurements and recruitment processes are workable. A feasibility aim is different from an efficacy claim: it asks whether the research process can produce usable information, not whether an intervention changes a clinical outcome. The registry lists feasibility topics, but it does not report detailed findings on them beyond the lack-of-enrollment reason for termination.

The design also highlights why a comparator matters. Even with completed baseline and follow-up measurements, a single-group study would mainly describe change over time rather than isolate a causal intervention effect. A control comparison and an appropriate analysis would be needed for a stronger causal estimate, while recognizing that design and measurement limitations would still matter.

Finally, the record demonstrates why planning calculations must be separated from observed evidence. The planning assumptions describe an illustration involving equal allocation between two arms and an observed effect, whereas this trial is listed as single-group and reports no outcome data. Keeping these concepts separate prevents hypothetical planning quantities from being mistaken for trial findings. The main statistical lesson is the importance of reporting feasibility, outcome availability, analysis populations, and the reasons no analysis could be 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.

Several limitations are specific to the available record. Enrollment was 2, and the study was terminated early due to lack of enrollment. The record explicitly states that no assays were run and there is no data to report. Consequently, the planned outcome measures cannot be summarized, and the intended preliminary description was not achieved in the posted results.

The study is listed as single-group, with allocation NA and masking NONE. No comparator is described, so even if outcome measurements had been available, changes over time would not establish that the intervention caused them. The record does not describe an analysis plan, sample-size justification, interim analyses, analysis population, or handling of missing data. These details are not reported in the registry record.

The intervention is described as Fiber-Stat at 2 tablespoons daily, and the purpose refers to 6 months of supplementation. The primary outcome timeframe is listed as 10 months. The record does not explain how that timeframe relates to the planned supplementation period or provide details about actual exposure and follow-up. Compliance is listed as a secondary topic, but results on compliance are not reported.

The outcome description includes several distinct measures, but it does not report their operational definitions, units, instruments, or planned statistical summaries. The record lists 2 outcome measures and 0 analyses, yet it does not explain the relationship between the measure count and the multiple concepts named in the primary description. The adverse-event entries likewise lack reported definitions and follow-up detail. These gaps limit interpretation beyond the clear statement that no outcome data are available.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pilot Study:Role of Dietary Fiber in PCOS Anovulation — NCT00703092.
• Registry record last updated 2017-10-09; status last verified 2017-09.
• Results first posted 2014-06-30.
• 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.

18. Record Summary

The registry record describes a phase 4, single-group pilot study of Fiber-Stat, taken as 2 tablespoons daily, in women with PCOS. The stated purpose was to assess preliminary measures at baseline and after 6 months of supplementation, including ovulation, insulin sensitivity, circulating androgens, and satiety. Feasibility topics were also listed.

Enrollment was 2, and the study was terminated early due to lack of enrollment. The record states that no assays were run and there is no data to report. It lists 0 analyses. No control group or randomized comparison is described.

For adverse events, the registry lists 2 at risk, 0 serious events, and 0 other events; deaths are null. The record does not report a sample-size justification, analysis plan, missing-data approach, or detailed safety follow-up. The posted information documents the study's aims and early termination, but does not provide outcome estimates.