Absorption Comparison on Equivalency Value of Genepro Gen2: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Absorption Comparison on Equivalency Value of Genepro Gen2 (NCT02919657), a non-randomized phase 4 study. The primary outcome is Weekly Blood Draws to Measure Blood Protein Levels.

2. Clinical Question

The registry describes both supplements as being used by each participant, with blood draws intended to measure blood protein levels. The primary outcome is a continuous measure in grams per deciliter, summarized as a mean with standard deviation. Each participant’s results were described as being averaged over each six-week testing period. The registry also describes assessing whether participants achieved a range set by dieticians: greater than 6.1 and less than 8.7, with a 10% variable accepted. The exact statistical role of that range in the primary comparison is not reported in the registry record.

The study title frames the comparison as one of equivalency. However, the registry record does not report outcome values, a defined equivalence margin, or an equivalence analysis. Without those details, the question can be stated as a comparison of blood protein measurements, but the posted record does not establish whether the study tested or demonstrated equivalence.

3. Trial Design

This is a Phase 4, completed study with a listed enrollment of 20. The registry identifies the design as a crossover, but allocation as nonrandomized and masking as none. The arm descriptions indicate that participants received both supplements in sequence: 10 participants were assigned Genepro Gen2 for the first six weeks and whey protein for the final six weeks, while 10 were assigned the reverse order. The registry’s description of the second sequence contains a wording error, but identifies whey protein as the first intervention and Genepro Gen2 as the later one.

Each intervention period is described as lasting six weeks, with weekly blood draws to measure blood protein levels. The outcome description says the reported measure was intended to represent the average over each six-week period for each sequence. A washout period between interventions is not reported in the registry record. Details about visit timing beyond the weekly draws, adherence assessment, and how measurements were handled if a participant missed a draw are also not reported.

The crossover structure means the same participant was intended to receive both supplements, rather than each participant remaining in only one treatment group. This structure can support within-participant comparisons, but the registry record does not report whether the analysis used that paired structure. Because treatment order was nonrandomized, differences between the sequences or changes over time could complicate interpretation. Masking was absent, so participants and relevant study personnel were not described as blinded.

The study start is listed as 2016-06, primary completion as 2016-09, and status as completed. The sponsor is Musclegen Research, Inc. Further details about the protocol, recruitment, participant characteristics, or reasons for any withdrawals 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.

Overall Study

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.

Population: 20 Post Op Gastric Bypass patients. 10 men, 10 women. All participants were between the ages of 30-46 years of age. All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.

6. Primary Endpoint

The registry lists the primary outcome as Weekly Blood Draws to Measure Blood Protein Levels, measured over 6 weeks per intervention.

The primary endpoint is weekly blood protein level, measured in grams per deciliter. The registry describes blood draws each week and a mean for each participant over each six-week intervention period. Standard deviation is named as the measure of dispersion. No actual means, standard deviations, participant-level values, or comparisons are reported in the registry record.

A continuous measurement retains more information about the observed level than a simple classification alone. A mean describes the central level in a group or period, while a standard deviation describes how dispersed observations are around that mean. In general, reporting both can help readers understand not only the average measurement but also how much participants’ measurements vary. The registry record does not include the values needed to apply that interpretation to this study.

The outcome description also refers to an average range set by dieticians: greater than 6.1 and less than 8.7, with a 10% variable accepted. The record does not explain precisely how that range was incorporated into the primary endpoint, whether it was used as a separate classification, or how the stated variability was applied. It is therefore not possible to determine from the posted record how many participants met the stated range, or whether that assessment was part of the reported primary analysis.

Blood protein level is the measurement chosen to compare the two supplement periods. The registry does not report evidence that this measurement is a validated substitute for any broader clinical outcome, and no such interpretation should be inferred from the endpoint description alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical method needed to answer the study question depends on the design and the endpoint. The endpoint is continuous, and the registry names the mean and standard deviation as its summary measures. The study is a crossover, so participants were intended to receive both interventions. For that structure, a comparison that accounts for each participant’s measurements across periods is generally more informative than treating the two intervention periods as unrelated groups. The registry record does not report the analysis method actually used.

What does a mean and standard deviation describe?

In general, a mean is a measure of the central level of a set of observations. A standard deviation describes the spread of observations around that mean. They answer different questions: the mean describes the average measurement, while the standard deviation describes variability among the measurements. Neither measure alone gives the uncertainty in a comparison between interventions. That uncertainty is commonly expressed with a confidence interval or another inferential summary. No such result is reported in the registry record.

The outcome description refers to measurements collected weekly and then averaged over each six-week period for each participant. That wording suggests that multiple observations were intended to contribute to a period-level summary, but it does not specify how the weekly values were aggregated, whether every scheduled draw was required, or how incomplete measurement series were handled. Those details matter because measurements from the same participant are related rather than independent observations. Treating repeated measurements as independent can misstate the amount of information in the data.

Why does the crossover structure matter?

In general, a crossover comparison can use within-participant differences: each participant serves as their own comparison across intervention periods. This can reduce the influence of stable characteristics that differ between people. The analysis still needs to account for the period in which each intervention was given and the order of interventions. A participant’s measurement may change over time for reasons unrelated to the supplement, and an earlier intervention could potentially affect later measurements. Whether such effects were assessed, and whether a washout period was used, are not reported in the registry record.

The record describes two intervention sequences, with 10 participants in each order, but says allocation was nonrandomized. In general, random assignment helps prevent systematic differences between groups or sequences from influencing comparisons. Nonrandomized sequence assignment leaves open the possibility that sequence groups differed in ways relevant to the outcome. The record does not describe adjustment for baseline differences or sequence effects. Masking is listed as none. In general, lack of masking can affect behavior, measurement, or decisions about study procedures, although the registry does not report that any such influence occurred.

How should uncertainty and equivalence be evaluated?

In general, a confidence interval gives a range of values compatible with the data and the statistical model, reflecting uncertainty in an estimate. A narrow interval indicates greater precision than a wide interval, but whether the estimate is meaningful depends on the question and any prespecified criteria. No confidence interval is reported for this study. The registry’s equivalency title does not itself define an equivalence margin. A margin and an analysis designed to assess equivalence are needed to interpret a comparison as evidence that two interventions are sufficiently similar. Neither is reported in the registry record.

The registry describes a sample-size planning illustration based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect, and that non-time-to-event outputs are expressed as participants per arm. These are descriptions of planning assumptions, not reported features of the trial’s own design justification. The registry record does not report a sample-size justification for the trial, the resulting planning values, or an observed effect on which to base an interpretation. Planning illustrations are not observed power and do not substitute for outcome estimates and their uncertainty.

What can be concluded from the analysis record?

The registry lists one outcome measure and zero analyses. It does not report the statistical model, significance tests, confidence intervals, handling of repeated measurements, or assumptions used for outcome analysis. General methods cannot fill those gaps. Any new reanalysis would require the underlying observations and a clearly specified analytic approach; neither is described in the registry record. Consequently, statistical interpretation is limited to the intended design, endpoint, and measurement schedule, not a comparative result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and zero analyses. That listing does not establish that the study collected or analyzed only one outcome in practice, nor does it provide a multiplicity plan. The registry record does not report whether there were secondary outcomes, multiple time points treated as separate hypotheses, subgroup analyses, or adjustments for multiple testing. With no reported analysis results, it is not possible to assess how many comparisons were conducted or whether their interpretation accounted for multiplicity.

Missing-data procedures are not reported in the registry record. Weekly blood draws were described across each six-week intervention period, but the number of expected and completed measurements is not given. The record does not state how missed draws, incomplete periods, withdrawals, or participants who did not complete both intervention periods were handled. It also does not report the number included in any primary analysis.

The analysis population is not defined. It is not clear whether the intended analysis included all enrolled participants, only those who completed both periods, or another group. In general, decisions about analysis populations and missing observations can affect the estimated comparison, especially in a crossover study where information from both periods may be needed for a within-participant contrast. Without these details or outcome data, the direction and extent of any such influence cannot be judged.

Thus, the posted record does not allow an assessment of multiplicity control, data completeness, or the sensitivity of the results to missing measurements. These are reporting gaps, not evidence that the study necessarily had missing data or conducted multiple analyses.

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

The record establishes that a completed crossover study was registered to compare Genepro Gen2 with whey protein isolate using weekly blood protein measurements. It describes the intervention order, period length, measurement unit, and intended summary. It does not report the measurements or a statistical comparison. Therefore, the record does not show whether average blood protein levels were higher, lower, or similar across intervention periods, and it does not indicate the precision of any difference.

The word “equivalency” in the study title should not be read as a reported finding. The registry record does not give an equivalence margin, an estimated difference, an uncertainty interval, or an equivalence analysis. In general, equivalence is a statistical question about whether a difference is sufficiently bounded within a prespecified range; it is not established merely because a study is called an equivalency study. The posted information is insufficient to decide whether the intended comparison met such a criterion.

Likewise, the absence of outcome results is not evidence that the interventions produced the same measurements, or that one produced a different measurement. It is an absence of evidence in the registry record. The listed enrollment and intervention schedule describe the planned study structure, but do not establish how many participants completed the periods or contributed to an analysis.

The stated dietician range is not accompanied by participant counts or analysis results. It is therefore not possible to determine how participants’ measurements related to that range. The adverse-event entries also do not support a conclusion about safety: zero participants at risk and zero affected are listed for the event categories, while deaths are not reported. These registry entries lack the information needed to estimate event frequencies.

In short, the posted record documents the study question and design but does not provide evidence from which to estimate a comparative effect or judge its clinical or statistical importance. No treatment recommendation follows from the registered information.

12. Why This Trial Matters Statistically

This study is statistically notable because it combines a continuous outcome with a crossover design. A crossover can make within-participant comparisons possible, which may be useful when participants differ in their underlying measurements. It also requires attention to treatment order, period effects, and the relationship between repeated measurements. The registry describes the sequence structure but does not report how those issues were handled analytically.

The nonrandomized allocation and absence of masking are important design features for interpretation. Nonrandomized sequence assignment may leave differences between sequence groups, while lack of masking can affect study conduct in ways that are difficult to assess from a registry description alone. Neither feature proves that bias occurred, but both make clear reporting of the analysis and data handling especially valuable.

The title’s equivalency framing also highlights the distinction between a study’s stated purpose and a result that supports that purpose. An equivalence question requires a defined margin and estimates precise enough to evaluate that margin. The registry record contains neither the margin nor outcome estimates. Its lack of posted analyses means that the central statistical question remains unanswered in the registry.

Finally, the weekly measurement schedule and the stated six-week period averages raise practical questions about repeated observations, completeness, and participant-level summaries. Reporting the number of usable observations, the treatment of incomplete periods, and the paired analysis would help readers assess the reliability of a comparison. The record does not report these details. These features make the study a useful example of why design descriptions alone cannot substitute for outcome estimates and transparent statistical methods.

13. 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 most direct limitation of the registry record is that it reports no outcome values or analyses for the primary endpoint. There are no period-specific means or standard deviations, no comparative estimate, and no uncertainty measure. The observed size and direction of any difference are therefore unknown from the posted information.

The design is described as nonrandomized and unmasked. These features can complicate interpretation, particularly when treatment order may relate to participant characteristics or when measurements change over time. The registry does not report methods for addressing sequence or period effects. It also does not report whether a washout period occurred, so the possibility of effects carrying over between intervention periods cannot be evaluated.

The listed enrollment is 20, with 10 participants described for each sequence. The number who completed both periods and the number contributing to the primary outcome are not reported. Participant characteristics, eligibility criteria, baseline measurements, and reasons for withdrawal are not reported in the registry record. This limits assessment of who the findings would represent even if outcome results were available.

The endpoint description does not fully clarify how weekly draws were combined, how the dietician range and its 10% variability were operationalized, or whether the range assessment was separate from the continuous endpoint. Missing-data procedures, analysis populations, and the statistical model are also not reported. Finally, the adverse-event entries list zero at risk and zero affected for each event category, while deaths are not reported; those entries do not provide sufficient context to assess adverse-event frequency.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Absorption Comparison on Equivalency Value of Genepro Gen2 — NCT02919657.
• Registry record last updated 2017-04-24; status last verified 2017-03.
• Results first posted 2016-12-01.
• 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.

17. Record Summary

NCT02919657 is a completed Phase 4 crossover study sponsored by Musclegen Research, Inc. The registry lists an enrollment of 20, nonrandomized allocation, and no masking. The study compares Genepro Gen2 Protein, described as a daily 1 tablespoon serving, with whey protein isolate, described as a daily 30g serving. Each intervention period is described as six weeks, with weekly blood draws to measure blood protein levels in grams per deciliter.

The primary outcome is described as a mean with standard deviation, based on measurements averaged over each intervention period. The study start is listed as 2016-06 and primary completion as 2016-09. One outcome measure is listed and zero analyses are reported. No outcome results or comparative statistical estimates are reported in the registry record, so the comparative result and its precision cannot be assessed.