Natreon Healthy Skin Study - PrimaVie Supplement: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Natreon Healthy Skin Study - PrimaVie Supplement (NCT02762032), a randomized phase 1 study. The primary outcome is Improvement in Non-invasive Skin Assessment of Skin Microperfusion.

2. Clinical Question

The study asks whether oral PrimaVie supplementation is associated with a change in skin microperfusion after 14 weeks, compared with a placebo control. The primary measure is skin microperfusion assessed non-invasively using laser speckle contrast imaging. The registry description says that an increase in Perfusion Units (PU) means improved skin perfusion.

This distinction matters: the study description states the intended question and the direction of the measure, but it does not establish what the observed data showed. The record identifies skin microperfusion as the primary outcome; it does not provide a numerical estimate of change, a measure of uncertainty, or a statistical test for the comparison. Other skin measures are named in the study title and brief summary, but the record does not specify their results in the information available for this analysis.

3. Trial Design

The registry describes a Phase 1, randomized, single-masked, parallel-group study. The listed enrollment is 45, and the arm descriptions specify 15 subjects randomized to each of three groups: PrimaVie 125 mg, PrimaVie 250 mg, or placebo. Each group is described as taking its assigned supplement twice daily for 14 weeks. The study is marked completed.

In a randomized design, assignment by chance is intended to make treatment groups comparable on average at the start of the study. That rationale is general; the registry record does not report the method used to generate the assignment sequence, how assignments were concealed, or whether the allocation process was implemented as planned. “Single” masking is the registry’s design label. Which people were masked, and how masking was maintained, are not reported in the registry record.

A parallel-group design assigns participants to a group and compares outcomes across groups rather than having each participant receive every intervention in sequence. Here, the described groups allow each PrimaVie dose to be considered against placebo. The record does not state the prespecified contrast or contrasts, whether dose groups were also compared directly with one another, or how the analysis accounted for baseline measurements.

The study lists healthy participants and the brief summary identifies the participants as females. More detailed inclusion and exclusion criteria, recruitment methods, study locations, adherence procedures, and the number of participants who completed follow-up are not reported in the registry record. The record gives a start date of 2016-02-20 and a primary completion date of 2018-12-01. It does not explain the interval between those dates or describe any changes to the study during that time.

The registry identifies Ohio State University as the sponsor. Registration information describes the planned intervention and outcomes, but the details needed to reconstruct the conduct and analysis of the trial are limited. In particular, the sample-size justification and full statistical analysis plan are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Subjects using medications for cardiovascular disease-related disorders (hydrochlororthiazide, aspirin, steroids, ACE inhibitors, beta-blockers and statins) were excluded from the study. Pregnant females and individuals being treatment for being immunocompromised were also not included.

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 Improvement in Non-invasive Skin Assessment of Skin Microperfusion, measured over 14 weeks after oral supplementation.

The primary endpoint is improvement in non-invasive skin assessment of skin microperfusion, measured in Perfusion Units (PU) at 14 weeks after oral supplementation. The registry describes measurement by laser speckle contrast imaging and states that an increase in PU means improved perfusion of the skin. The endpoint is continuous, and the intended summary is a mean with standard deviation.

Microperfusion concerns blood flow in small vessels within tissue. As a general measurement principle, an objective instrument-based measure can provide a more standardized assessment than a subjective rating, provided that measurement procedures are consistent. The registry does not describe those procedures in enough detail to assess their reproducibility, nor does it report the instrument settings, measurement locations, or the timing of assessments beyond the stated 14-week timeframe.

Using a continuous measure retains more detail than dividing participants into categories such as improved or not improved. In general, a mean describes the group’s average measurement, while a standard deviation describes the spread of individual measurements around that average. Those summaries can help readers understand both the group-level result and the variability among participants. They do not, on their own, show the difference between treatment groups or the precision of that difference.

The primary endpoint is narrower than the broader study aims, which also mention hydration, elasticity, and barrier function. The registry record does not report numerical results for microperfusion or establish how the other skin measures relate to it. Without outcome estimates and uncertainty measures, the magnitude and precision of any group differences cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group study with three arms and a continuous primary outcome. These features establish the broad framework for analysis, but they do not identify the statistical test or model used for the final results. The statistical analysis plan is not reported in the registry record.

What a mean and standard deviation describe

For a continuous measure such as PU, the mean is the arithmetic average of participants’ measurements in a group. The standard deviation describes how dispersed individual measurements are around that average. These are descriptive summaries. A mean can help characterize the typical level in a group, while the standard deviation helps show whether participant measurements cluster closely or vary considerably. Neither alone is an estimate of a treatment effect: that requires a defined comparison between groups or between measurements over time.

In general, an analysis might compare endpoint means, changes from baseline, or adjusted means. Those approaches answer related but not identical questions and can produce different estimates when baseline values are considered. Which approach was used, whether baseline adjustment was planned, and whether any covariates were included are not reported in the registry record. There is also no reported estimate or confidence interval with which to assess the size and precision of a comparison.

Randomization and the group comparison

Randomization is intended to reduce systematic differences between groups at assignment. It does not ensure that groups will be identical, especially in a modest-sized study, and it does not resolve biases arising after assignment, such as missing outcomes or differences in adherence. These are general considerations. The registry identifies randomization but does not report the sequence-generation or concealment methods, adherence information, or the handling of participants who did not complete follow-up.

The two dose arms and placebo arm create more than one possible comparison. A statistical analysis should define which comparisons address the main question and how additional comparisons are treated. The record does not state the planned primary contrast, whether comparisons between both doses and placebo were separately tested, or whether the two active doses were compared with each other. The primary outcome is described as having several categories or time points, without a single reduced comparison in the registry record.

Uncertainty and statistical evidence

In general, a confidence interval communicates uncertainty around an estimated effect. A narrower interval indicates greater precision under the analysis assumptions, while a wider interval indicates less precision. A p-value is interpreted in relation to a specified null hypothesis and statistical model; it is not the probability that the null hypothesis is true. Neither a confidence interval nor a p-value is reported for the primary outcome in the registry record. Therefore, its statistical uncertainty cannot be evaluated from the posted information.

For continuous outcomes, a normal approximation may be used in some analyses when its assumptions are considered reasonable. The assumptions used in the trial’s primary analysis are not reported. In general, skewed distributions, influential observations, or unequal variability can make a simple normal-based analysis less suitable, depending on the data and model. The record provides no distributional summaries or diagnostic information for assessing those considerations.

Planning calculations are not trial results

The registry’s sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The intended effect to detect is expressed as a stated fraction of the observed effect. Those assumptions describe a planning calculation, not the trial’s own design justification; the actual sample-size justification is not reported in the registry record. The record does not provide the observed effect needed to interpret such illustrations in substantive terms.

Sample-size planning asks how many participants per arm would be needed under specified assumptions to detect a target difference with a chosen power and significance level. It depends on the assumed effect, variability, analysis, and allocation. A planning illustration cannot establish the power actually achieved after the study, and it is not observed power. Because the primary-outcome estimate and its variability are not reported, the illustrations cannot be assessed against the trial’s results from the registry record.

Limits of reconstruction

The record lists 21 outcome measures and 50 analyses, but those totals do not specify the models, contrasts, or decision rules. The analysis population, treatment of missing measurements, adjustments for multiple testing, and any interim analyses are not reported in the registry record. Thus the design label and outcome description support a general account of how continuous outcomes are often analyzed, but they do not allow reconstruction of this trial’s actual inferential methods.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 21 outcome measures and 50 analyses. It also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. These features make it important to know which outcomes, time points, and contrasts were designated in advance as primary, and how the investigators handled the chance of false-positive findings across multiple tests. The prespecified testing hierarchy and any multiplicity adjustment are not reported in the registry record.

As a general statistical issue, testing many hypotheses can increase the chance that at least one result appears statistically notable by chance alone. Procedures for controlling that risk may adjust significance thresholds or interpret groups of tests together. The appropriate approach depends on the study’s objectives and planned comparisons. The count of analyses alone cannot establish whether multiplicity was addressed or whether the primary question was protected from selective emphasis.

Missing data can also affect interpretation. If outcome measurements are unavailable for some participants, the results may depend on why they are missing and how the analysis handles them. The registry does not report the number of participants with measured primary outcomes, reasons for missingness, imputation methods, or sensitivity analyses. It also does not specify whether all randomized participants were included in the primary analysis or whether a different analysis population was used.

The registry describes the planned group assignments and follow-up timeframe, but those details do not establish completeness of outcome data or the analysis population. Without these reporting details, readers cannot assess the extent to which missing measurements or multiple analyses may have influenced the reported evidence. Numerical primary-outcome results are not reported in the registry record.

11. 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.

The registry reports zero serious adverse events among 15 participants at risk in each of the three arms. It also reports zero other adverse events among 15 at risk in each arm, and zero deaths in each arm. No serious adverse event terms are listed.

These are event counts as recorded, not a guarantee that no adverse events occurred outside the registry’s reporting categories or observation process. A count of zero in a group describes what the registry reports for that group; it does not show that the underlying risk is zero. In general, safety estimates based on small groups can be imprecise, and the absence of reported events cannot rule out uncommon events.

The record does not describe the adverse-event collection period, definitions, monitoring procedures, severity grading, or whether all participants contributed safety follow-up. The phrase “other adverse events” is reported as a separate count from serious adverse events, but further category details are not reported in the registry record. The figures should therefore be read as the posted counts, with the limits of the available reporting in mind.

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

The registry record establishes that a randomized, three-arm study of PrimaVie supplementation in healthy females was completed. Its primary endpoint was skin microperfusion measured in PU at 14 weeks after supplementation. The record explains that an increase in PU represents improved perfusion, and it describes two PrimaVie doses and a placebo control.

Those design details define the question the study was intended to address. They do not provide the answer. Numerical results for the primary endpoint are not reported in the registry record, so readers cannot estimate a change within any group or a difference between groups. The absence of posted estimates also means that the precision of any possible difference cannot be judged. There is no basis in the record for deciding whether the results were compatible with no difference, a potentially important difference, or a range of effects.

In general, an estimate should be interpreted together with its uncertainty and the design of the analysis. A statistical test alone, even if one were reported, would not determine practical importance. A meaningful interpretation would also depend on the measurement’s reliability, the relevance of the size of any change, and whether the groups and time points were analyzed as planned. Those matters cannot be assessed from the information recorded for the primary outcome.

The title and study summary refer to hydration, elasticity, and barrier function as additional areas of interest. They do not supply numerical results for those measures. The registry’s counts of outcome measures and analyses do not substitute for estimates or establish which findings are most relevant. Similarly, the adverse-event counts describe the events recorded but do not establish that the supplement is free of risk.

The appropriate reading is therefore bounded: the record documents the study design, intended intervention period, endpoint, and posted safety counts, but it does not report the primary outcome findings needed to quantify the result. This reporting gap is not evidence that the intervention had no effect, nor is it evidence that it had an effect.

13. Why This Trial Matters Statistically

This trial is statistically notable for the gap between a clearly described design and the absence of numerical primary-outcome results in the registry record. The design identifies a randomized comparison of two supplement doses with placebo, a continuous endpoint, and a stated assessment timeframe. Those elements show what sort of question the investigators set out to examine. Without the outcome estimates and their uncertainty, however, the central comparison cannot be evaluated quantitatively.

Continuous outcomes are often informative because they retain the scale of measurement rather than reducing observations to categories. But they still require transparent reporting: group summaries, a defined comparison, and uncertainty around the estimate. The mean and standard deviation are identified as the intended summary, yet the values are not reported for the primary endpoint. This leaves readers unable to distinguish the size of a possible effect from the variation among participants or to assess precision.

The study also illustrates why multiplicity details matter. The record lists many outcome measures and analyses and notes several categories or time points for the primary outcome, but does not identify a single comparison or explain how testing across outcomes was handled. In general, prespecified analysis choices help readers understand how a result relates to the main research question rather than to one of many possible comparisons.

Finally, a completed status and a listed enrollment are not substitutes for analyzed participant counts or results. The registry does not report the analysis population, missing-data handling, or the trial’s statistical analysis plan. These omissions limit reproducibility and the ability to judge how closely the reported analyses would address the intended question. The study’s statistical importance in the available record is therefore primarily about what can and cannot be inferred from its reporting.

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 for this study. Although the study is marked completed and lists an enrollment of 45, numerical results for the primary endpoint are not reported. The record therefore does not show group means, standard deviations, changes, treatment contrasts, confidence intervals, or p-values for skin microperfusion. This prevents assessment of the result’s magnitude and precision.

The endpoint is described as a 14-week assessment, but baseline values and any other measurement time points are not detailed in the primary outcome information. The record also notes that the primary outcome has several categories or time points and is not reduced to one comparison. The prespecified primary contrast and the relationship between the outcome entries and analyses are not reported.

The arm descriptions specify 15 subjects randomized to each group, but the number with outcome measurements, the number completing follow-up, and the analysis population are not reported in the registry record. Reasons for withdrawal or missing measurements and methods for handling missing data are also not reported. The degree to which follow-up data were complete cannot be assessed.

Further design and analysis details are unavailable, including the randomization method, allocation concealment, the identity of masked parties, baseline-adjustment strategy, statistical model, multiplicity approach, and sample-size justification. Measurement procedures beyond the named imaging method are not described in enough detail to assess reliability or reproducibility. The record’s safety counts likewise lack details on the event-collection period and monitoring procedures.

These limitations concern reporting available in the registry record; they do not establish what analyses may have been conducted elsewhere. Without additional reported outcome and methods information, readers cannot reconstruct the primary analysis or determine whether the intended comparisons were carried out as planned.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Natreon Healthy Skin Study - PrimaVie Supplement — NCT02762032.
• Registry record last updated 2026-06-25; status last verified 2026-03.
• Results first posted 2026-06-25.
• 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 completed Phase 1 randomized, single-masked, parallel-group study sponsored by Ohio State University. It lists 45 participants and describes three arms of 15 subjects: PrimaVie 125 mg twice daily, PrimaVie 250 mg twice daily, and placebo twice daily, each for 14 weeks. Participants are described as healthy females.

The primary outcome is skin microperfusion in PU, assessed 14 weeks after supplementation. An increase in PU is described as improved perfusion. The registry lists 21 outcome measures and 50 analyses, and notes that the primary outcome includes several categories or time points rather than one reduced comparison. Numerical primary-outcome results and details of the statistical analysis are not reported in the registry record.

For each arm, the record reports zero serious adverse events, zero other adverse events, and zero deaths among 15 at risk. The study start date is 2016-02-20, and the primary completion date is 2018-12-01.