Monocyte Priming When Consuming a Western Diet: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Monocyte Priming When Consuming a Western Diet (NCT05348395), a na na study. The primary outcome is Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity.

2. Clinical Question

In practical terms, the study was designed to examine a biological measure during a controlled feeding trial, rather than to compare clinical outcomes between randomized treatment groups. The registry summary frames the research as an investigation of the mechanism of monocyte priming in humans. It describes the dietary exposure and the intended population, but it does not report whether the planned diet was fully consumed, how the measure changed over time, or whether any observed change met a prespecified statistical criterion. Those omissions limit what can be concluded from the registry record about the primary research question.

3. Trial Design

The registry describes a completed, single-group feeding trial, with an enrollment of 8. Its title is “Monocyte Priming When Consuming a Western Diet,” and the official title identifies it as a feeding trial focused on the mechanism of monocyte priming in humans. The listed phase is NA. The study began on 2023-01-06, reached primary completion on 2024-10-11, and has a status of COMPLETED.

The planned population was normal-weight and metabolically healthy people aged 20–45 years. The brief summary describes an 8-week Western diet characterized as high in saturated fat, fructose, and calories. The experimental diet was intended to provide 15% of calories from saturated fat and 14% from fructose, with a goal of providing 1.25x total energy needs. These descriptions specify the planned dietary exposure; the registry record does not report adherence, actual energy intake, or whether each participant received the intended dietary composition.

There is no randomized allocation or concurrent control group. Masking is recorded as NONE, and the study model is SINGLE GROUP. Consequently, the design does not support a randomized, between-group comparison of the experimental diet with a control diet. Any interpretation of change within participants would depend on the actual measurement schedule and analysis, neither of which is fully described in the record.

The primary outcome is MKP-1 activity, with a continuous measure reported in ng/mg protein and a mean with standard deviation specified as the summary type. The stated timeframe is “Baseline (experimental phase).” The record also lists RNA analysis as a secondary outcome. It does not report the full protocol, the number or timing of all measurements, a statistical analysis plan, or an explanation of how the planned outcome measures relate to the enrollment target.

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.

Run-In Phase (10-14 Days)

Experimental Phase (8 Weeks)

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 Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity, measured over Baseline (experimental phase).

The primary endpoint is measurement of mitogen-activated protein kinase phosphate 1 (MKP-1) activity, expressed in ng/mg protein. The registry description says plasma from all subjects would be analyzed for plasma lipid composition, using ELISA to quantify MKP-1 protein in blood monocytes. The endpoint is specified as continuous, with the mean and standard deviation as its intended descriptive summary.

In general, a continuous biological measurement can describe the level of a marker across participants and can be used to examine change if measurements are collected at more than one time. The registry’s research question concerns the mechanism of monocyte priming, so a cellular protein measure is relevant to the stated mechanistic focus. This general rationale does not establish that the endpoint is a validated surrogate for a clinical outcome, nor does the registry record make that claim.

The timeframe is recorded as “Baseline (experimental phase),” which does not by itself clarify whether the reported endpoint represents a baseline value, a value during the diet, or a change between measurements. The record does not report the measurement values, the standard deviation, a change estimate, a confidence interval, or a test of statistical significance. It also does not explain whether the endpoint was assessed at additional time points. The registry therefore identifies what was intended to be measured, but does not provide the results needed to judge the magnitude or precision of any observed difference or change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as continuous and specifies a mean with standard deviation. It does not report an analysis of the endpoint, so the statistical methods below explain how these concepts are generally used rather than describing methods confirmed for this trial.

What does a mean describe?

General explanation: a mean summarizes the central level of a continuous measurement across the observations included in an analysis. For a biological measure such as MKP-1 activity, it can provide a compact description of the group’s measured values. A mean alone does not reveal how widely individual measurements vary, whether a small number of observations strongly influence the summary, or whether the observed values are distributed symmetrically.

The registry’s specified unit is ng/mg protein, and the named summary is mean with standard deviation. The standard deviation describes the spread of individual values around the mean. It is not the same as a confidence interval: a standard deviation describes participant-level variability, while a confidence interval expresses uncertainty around an estimated quantity. Neither the mean nor the standard deviation is reported as a result in the registry record.

What would a change estimate mean?

General explanation: when measurements are taken at multiple times, an analysis may estimate the average within-participant change. Such an estimate is different from comparing two independent groups, because repeated values from the same person are related. The registry gives a timeframe of “Baseline (experimental phase),” but it does not describe all measurement occasions or report a change estimate. No before-and-after result should be inferred from the timeframe label alone.

In a single-group design, a measured change can describe what happened among participants during the observation period. It does not, by itself, establish that the intervention caused the change. Without a concurrent comparison group, other time-related influences cannot be separated from the diet-associated pattern using a randomized between-group contrast. This is a design limitation, not a flaw in the arithmetic of a within-participant summary.

How should uncertainty be understood?

General explanation: a confidence interval is a range of values compatible with the data and the assumptions of the statistical method. It communicates estimation uncertainty, rather than the range containing most individual participant measurements. Its width depends on features such as variability, sample size, and the analysis model. The registry record does not report a confidence interval for MKP-1 activity or identify a model used to calculate one.

A p-value, when reported, measures how unusual the data would be under a specified null hypothesis and statistical model. It does not give the probability that the null hypothesis is true, and it does not indicate the size or practical importance of an effect. No primary-outcome p-value is reported in the registry record, so the data cannot be characterized as statistically significant or not significant on that basis.

What can the enrollment tell us?

The enrollment is 8. Enrollment is a count of participants recorded for the study; it does not itself indicate how many contributed usable measurements to a particular analysis. The analysis population, missing outcome values, and reasons for any missing measurements are not reported in the registry record. Without those details, the number contributing to a primary outcome estimate cannot be confirmed from the enrollment figure alone.

The registry includes sample-size planning assumptions for a separate planning illustration: 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 an observed effect. Those assumptions are not a description of this single-group trial’s design, and no resulting planning counts are reported in the record. Such illustrations are not observed power and do not show that the study was designed to detect a particular effect. The registry does not report the trial’s own sample-size justification.

Why can variability matter?

General explanation: biological measurements may vary among participants, and unusually dispersed data can make a mean less informative as a stand-alone description. A method that assumes the variability is well represented by a particular distribution may give unreliable uncertainty estimates if that assumption is unsuitable. When count outcomes show variability beyond the model’s expectation, over-dispersion can make standard errors too small unless the analysis accounts for it. That concept is not a claim about this trial: the primary endpoint is continuous, and the registry does not report its distribution or an analysis model.

For repeated measurements, a suitable analysis also needs to account for the association among observations from the same participant. General methods can include models that represent within-person correlation, but the record does not identify a repeated-measures model or any other method used for the endpoint. It would be inappropriate to assign a particular method to this study without a reported analysis.

In short, the registry names a continuous endpoint and its intended descriptive statistics, but does not give the estimates or inferential methods needed to assess effect magnitude and precision. General statistical definitions help explain what those quantities would mean; they do not fill in missing trial results.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Experimental Diet")
n   <- c(8)
m   <- c(6.71)
sp  <- c(1.33)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Experimental Diet  8  6.710  1.330  5.598  7.822

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, including the primary MKP-1 activity measure and RNA analysis as a secondary outcome. It reports 0 analyses. The record does not state which outcomes were analyzed, which were prespecified for inferential testing, or whether any adjustment for multiple comparisons was planned or performed. It also does not describe a hierarchy among secondary outcomes.

General explanation: when many outcomes or repeated tests are examined, the chance of obtaining at least one apparently notable result can increase. Prespecifying a primary endpoint and analysis can help clarify which question is central; adjustment procedures can also be used when appropriate. These are general statistical considerations, not evidence that multiplicity was or was not handled in this trial.

Missing-data methods are not described. The record does not report how many participants contributed data to each outcome, whether any endpoint measurements were missing, why data might be missing, or how missing observations were handled. Enrollment of 8 does not establish the number analyzed for the primary measure. It is therefore not possible to determine whether the planned analysis used all enrolled participants or a subset.

The record does not define an analysis population, such as all enrolled participants or those with complete endpoint measurements, and it does not report exclusions from analysis. It also does not report a statistical analysis plan, sensitivity analyses, or methods for handling deviations from the planned diet. These details matter because different analysis populations or missing-data assumptions can yield different estimates. In their absence, the analysis population and the robustness of any result are not reported in the registry record.

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 registry records 0 serious adverse events among 8 participants at risk in the experimental diet group. It records other adverse events affecting 6 of 8 participants at risk, and 0 deaths. No serious adverse event terms are listed. These are the safety counts reported in the registry record; they do not provide a detailed description of the events classified as other adverse events.

General explanation: a serious adverse event is a specific safety category, while an adverse event is a broader category. The absence of reported serious events does not mean that no non-serious events occurred; in this record, other adverse events are reported separately. An event count also does not by itself establish that the intervention caused an event. The record does not report event descriptions, timing, severity details for other events, or attribution to the diet.

The figures should be read as counts within a small, single-group study, not as a comparison of risks between diets. No concurrent control group is described, and no inferential safety comparison is reported. These registry entries do not establish the full safety profile of the dietary intervention or indicate how frequently particular event types occurred.

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

The registry establishes that this completed study enrolled 8 participants and was designed as a single-group feeding trial of a Western diet. The planned exposure was described as lasting 8 weeks, with specified proportions of calories from saturated fat and fructose and a goal of providing 1.25x total energy needs. The primary endpoint was MKP-1 activity, expressed in ng/mg protein, with a mean and standard deviation specified as its summary.

Those design details explain the question the study set out to address, but the registry record does not report the primary outcome values or a statistical analysis. It cannot show whether MKP-1 activity increased, decreased, or remained similar during the study. It also cannot establish the size or precision of a change, or whether any change met a statistical criterion. The endpoint timeframe, “Baseline (experimental phase),” does not clarify the full measurement schedule.

The single-group design is important for interpreting any potential within-person pattern. Without a concurrent control group, changes during the feeding period cannot be separated from other influences through a randomized comparison. The dietary description also reflects the planned intervention; adherence and actual intake are not reported. Thus, the record does not establish the degree of exposure each participant received.

The safety entries record 0 serious adverse events among 8 at risk, other adverse events affecting 6 of 8, and 0 deaths. These figures do not identify the types or causes of other events, and they are not a controlled comparison. They describe the registry’s safety reporting, not a comprehensive assessment of risks.

In general, mechanistic biomarker studies can contribute information about biological responses, but a biomarker result is not automatically equivalent to a clinical outcome. The registry does not claim that MKP-1 activity predicts a health outcome, and it does not report clinical outcome results. The record therefore supports a description of the study’s purpose and design, but not a conclusion about the direction or magnitude of its primary result, causal effects, or clinical implications.

14. Why This Trial Matters Statistically

This study raises statistical issues that are important in small mechanistic feeding trials. First, the distinction between a planned endpoint and a reported endpoint result is essential. The registry names MKP-1 activity as the primary measure and specifies a mean with standard deviation, but does not report numerical outcome findings. A design description cannot substitute for an estimate, and a completed status is not a statistical result.

Second, a single-group design places limits on causal interpretation. Repeated measurements can describe participant-level change, but without a concurrent control group they cannot separate a diet-associated change from other influences over the same period. This distinction remains important even when the dietary exposure is carefully described.

Third, a small enrollment makes transparent reporting of participant flow, measurement completeness, and uncertainty especially useful. The registry records an enrollment of 8, but does not report the number analyzed for the primary outcome or the distribution of the observed values. Without those details, readers cannot assess how representative the summary is of individual participants or how precisely it estimates a group-level quantity.

Finally, this record illustrates why the analysis plan and outcome reporting matter. It lists 4 outcome measures and 0 analyses, without describing multiplicity handling, missing-data methods, or the statistical model. These omissions do not prove that particular methods were absent from the conduct of the study; they mean those methods are not reported in the registry record. Clear reporting of estimates, uncertainty, analysis populations, and the relationship between planned and completed measurements would be needed for a fuller statistical interpretation.

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 registry record does not report the primary MKP-1 result, its standard deviation, a change estimate, a confidence interval, or a p-value. This prevents assessment of the direction, magnitude, and precision of the primary endpoint findings. Although the study status is COMPLETED, no numerical primary outcome result is available in the record.

The study is described as single-group, with allocation recorded as NA and masking as NONE. There is no concurrent control group, so a randomized between-group estimate is not available. The record does not report the full measurement schedule, and the primary timeframe label, “Baseline (experimental phase),” does not clarify whether the endpoint refers to baseline measurement or another point in the experimental phase.

The registry describes a planned 8-week diet and its intended nutritional composition, but adherence and actual intake are not reported. It also does not provide participant characteristics beyond the planned population description, or explain whether all enrolled participants completed the intervention and contributed endpoint data. Enrollment of 8 does not establish the number included in each outcome analysis.

The record does not report a statistical analysis plan, methods for missing data, the analysis population, multiplicity procedures, or sensitivity analyses. The count of 4 outcome measures and 0 analyses does not supply those details. Safety reporting is also limited: other adverse events are counted, but their terms and attribution are not listed. These record-level limitations restrict interpretation; they do not establish what methods or observations may have been documented elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Monocyte Priming When Consuming a Western Diet — NCT05348395.
• Registry record last updated 2026-03-06; status last verified 2024-12.
• Results first posted 2026-03-06.
• 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

NCT05348395 is a completed, single-group feeding trial titled “Monocyte Priming When Consuming a Western Diet.” The registry records an enrollment of 8 and describes a planned 8-week Western diet for normal-weight, metabolically healthy people aged 20–45 years. The experimental diet was intended to provide 15% of calories from saturated fat and 14% from fructose, with a goal of providing 1.25x total energy needs.

The primary outcome was MKP-1 activity in ng/mg protein, specified as a continuous measure summarized by mean and standard deviation. RNA analysis is listed as a secondary outcome. The registry does not report primary endpoint values or statistical analyses. Safety entries include 0 serious adverse events among 8 at risk, other adverse events affecting 6 of 8, and 0 deaths. No concurrent comparator group is described.