Oatmeal Effect on N-acyl-phosphatidylethanolamines: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Oatmeal Effect on N-acyl-phosphatidylethanolamines (NCT03468179), a na na study. The primary outcome is Change in Serum N-acyl-phosphatidylethanolamine (NAPE).

2. Clinical Question

The study asks whether an acute oatmeal challenge is followed by a change in serum NAPE. The registry summary describes NAPEs and their active metabolites, N-acyl-ethanolamides (NAEs), as lipid satiety factors normally biosynthesized in the intestinal tract in response to food intake. It also describes a hypothesis that a single dose of oatmeal could raise plasma NAE from baseline, with possible effects on satiety and basal metabolic rate. These are the rationale and hypothesis, not reported findings from this study.

The listed primary endpoint is change in serum NAPE from baseline to 120 minutes post-oatmeal challenge. Serum NAPE and serum NAE are also listed among the secondary outcomes. The summary says serum glucose and subjective satiety would be monitored, but their outcome results are not reported in the registry record. The central statistical question is therefore a within-participant change question, not whether oatmeal differs from a randomized alternative. The size, direction, and precision of the NAPE change are not reported in the registry record.

3. Trial Design

The study is registered as a completed, single-group trial of oatmeal, with enrollment of 10. The intervention is listed as a dietary supplement. Participants were to arrive fasting, have intravenous access obtained, and provide a baseline blood sample before receiving oatmeal. The serving is described as 80gm/100kg. Blood was to be drawn at 30, 60, 90, and 120 minutes. The primary endpoint timeframe is baseline to 120 minutes.

The design is not a randomized comparison: allocation is recorded as NA, and the registry characterizes the model as single-group. Masking is listed as none. There is no separate control arm in the record, so any interpretation of change would rely on comparison with baseline rather than a contemporaneous untreated or alternative-treatment group. This design can describe measurements over the challenge period, but by itself it does not separate an oatmeal-associated change from other influences that could affect measurements over time.

The study is listed as phase NA and completed. The recorded start date is 2018-10-07, and the primary completion date is 2018-12-31. Vanderbilt University Medical Center is listed as the sponsor. The registry record does not report the protocol details beyond the described fasting visit, oatmeal serving, and blood-draw schedule. In particular, it does not report a rationale for the enrollment target, details of participant eligibility, or a statistical analysis plan.

The stated monitoring includes serum glucose, NAPE and NAE levels, and subjective satiety. The primary outcome is the change in serum NAPE; the listed secondary outcomes are serum NAPE and serum NAE. Although the record lists 3 outcome measures, it does not report numerical outcome results or analysis estimates. The study design therefore establishes what was intended to be measured and when, but the registry record does not permit assessment of the measured response.

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Serum N-acyl-phosphatidylethanolamine (NAPE), measured over Baseline to 120 minutes.

The primary endpoint is change in serum N-acyl-phosphatidylethanolamine (NAPE), measured in nmol/L, from baseline to 120 minutes after the oatmeal challenge. NAPE is the circulating lipid measure selected to address the study’s acute-response question. The registry summary describes NAPEs as related to NAEs, which are characterized there as active metabolites and lipid satiety factors. The endpoint is a laboratory measure; it is not itself a direct measure of appetite, food intake, weight change, or metabolic rate.

Using baseline as the reference allows each participant’s later measurement to be interpreted relative to their pre-oatmeal measurement. In general, a change endpoint can summarize the direction and magnitude of a response over a defined interval. It does not, in a single-group study, establish that the intervention caused that change, because there is no separate comparison group to account for changes that might occur over time for other reasons.

The primary measure is specified as a mean, with standard error as the stated dispersion measure. In general, the mean describes the average change across the analyzed observations, while the standard error describes the uncertainty in estimating that mean. The actual mean change, its standard error, the number of observations contributing to the endpoint, and any confidence interval are not reported in the registry record. The endpoint definition is available, but its observed value and precision cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a change in serum NAPE measured in nmol/L. The registry specifies the mean as the summary measure and standard error as the dispersion measure. These specifications describe how an outcome could be summarized; they do not supply the numerical result. The estimated mean change, standard error, confidence interval, and test result are not reported in the registry record.

What does a mean change describe?

In general, a mean change combines individual changes into an average for the analyzed participants. A positive mean would indicate an average increase under the direction convention used, and a negative mean would indicate an average decrease. The registry record does not provide a value or sign, so neither pattern can be attributed to this study. A mean also does not show whether individual participants had similar responses or widely differing responses; those details would require participant-level data or additional summaries, which are not reported.

What does the standard error describe?

In general, the standard error expresses the uncertainty of an estimated mean, rather than the spread of individual measurements. It is useful for judging how precisely an average has been estimated. The standard deviation, which describes variation among observations, is not the stated dispersion measure for the primary outcome. Neither the standard error nor a standard deviation is reported numerically in the registry record. A confidence interval is also not reported. Without these quantities, precision cannot be described, and no estimate should be inferred from the design description.

Why does the single-group design matter?

The planned comparison is between baseline and a later measurement in the same study group. In general, repeated measurements can account for the fact that each participant has a baseline value, but a before-and-after comparison is not equivalent to a randomized comparison. There is no separate group in this record that could show what would have happened over the same period without oatmeal or with another intake. Any observed change would therefore be descriptive of the study period and could not, by itself, distinguish the intervention from other causes of change.

The record says participants would arrive fasting, provide a baseline blood sample, receive the oatmeal serving, and have blood drawn at 30, 60, 90, and 120 minutes. This timing establishes the intended sequence of measurement. It does not establish how samples were processed, whether all scheduled samples were obtained, how deviations were handled, or how repeated measurements were analyzed. Those details are not reported in the registry record.

How should tests and confidence intervals be read?

In general, a statistical test evaluates how compatible the observed data are with a specified null hypothesis under the assumptions of the test. A p-value does not measure the size or importance of an effect, and it does not establish causation. A confidence interval gives a range of values compatible with the data and the interval procedure; its width conveys precision. The registry record reports no p-value, test, confidence interval, or model for the primary outcome, so none can be interpreted for this study.

The registry record lists 0 analyses. This means the record does not supply a reported analysis to interpret. It does not imply that the study collected no measurements, nor does it identify what analysis may have been conducted outside the registry. An analysis plan, any covariate adjustment, and handling of repeated measurements are not reported in the registry record.

What do the planning assumptions mean?

The record describes a planning illustration based on an observed effect, with 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. These are planning assumptions, not a description of the actual single-group design. The registry record explicitly says the illustration is not the trial’s own design. It also does not report the numerical planning results in the registry record for this analysis. Such planning values are not observed power and cannot be treated as evidence about the study’s outcome.

In general, over-dispersion means that variability is greater than a chosen statistical model expects. When present, it can make standard errors or tests based on an overly restrictive variance assumption misleading. The registry record does not report an over-dispersion assessment or a model for the primary endpoint, so this concern cannot be evaluated for this trial. More broadly, statistical methods can only be judged in relation to their assumptions and the data analyzed; those details are not available in the registry record.

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("Oatmeal")
n   <- c(10)
m   <- c(-4.02)
sp  <- c(10.57)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
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  Oatmeal  10  -4.020  33.425  -27.931  19.891

11. Multiplicity, Missing Data and Analysis Populations

The registry record names serum NAPE and serum N-acyl-ethanolamides (NAE) as secondary outcomes, alongside the primary serum NAPE change endpoint. The study summary also says serum glucose and subjective satiety would be monitored. The record lists 3 outcome measures, but does not report the numerical findings for these measures or explain how outcomes were prioritized in analysis. A statistical plan for handling multiple outcomes or multiple time points is not reported in the registry record.

In general, testing several outcomes or time points can increase the chance of finding an apparently notable result by chance if no adjustment or prespecified strategy is used. Whether adjustment is appropriate depends on the scientific questions and analysis plan. Since the record does not report tests, estimates, or a multiplicity strategy, it is not possible to determine how this issue was addressed. The scheduled blood draws do not, by themselves, establish which time points were tested or how those comparisons were treated.

Missing-data handling and the analysis population are also not reported in the registry record. Enrollment is listed as 10, but the record does not state how many participants had baseline and 120-minute NAPE values, whether any measurements were missing, or how missing observations were handled. The record does not describe exclusions, protocol deviations, or whether analysis followed an intention-to-treat or another population definition. These omissions limit assessment of both potential bias and the precision of any estimate.

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 record lists 0 serious adverse events among 10 at risk in the oatmeal group. It lists 1 other adverse event among 10 at risk and 0 deaths. These are registry counts, not estimates of comparative risk: there is no separate control group in this single-group study. The record does not identify the other adverse event in the listed information, and no serious adverse event terms are listed.

The counts should be read as reported safety entries, not as proof that an event was or was not caused by oatmeal. The record does not report event descriptions, severity details for the other event, timing, assessment of relatedness, or a narrative explaining the safety entries. Nor does it provide enough information to evaluate how completely events were collected or whether all participants completed safety follow-up. The at-risk counts are presented as recorded; no additional proportions or comparisons are calculated. These entries describe what the registry lists, but do not establish a broader safety profile.

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

The registry record establishes that a completed study was designed to measure acute serum responses after a single weight-based oatmeal serving. It identifies a primary endpoint of serum NAPE change from baseline to 120 minutes and gives the planned fasting and blood-draw schedule. It also records enrollment of 10 and lists serum NAE as a secondary outcome. These registry entries describe the study question and procedures, not the outcome.

The record does not report the primary outcome estimate, its standard error, a confidence interval, or an inferential test. It therefore does not show the magnitude, direction, or precision of the serum NAPE change. Findings for NAE, glucose, and subjective satiety are also not reported in the registry record. The study hypothesis about a possible rise in NAE and possible effects on satiety or basal metabolic rate must not be read as a result.

Even if a pre-to-post change were reported, the single-group design would not establish that oatmeal caused it. Without a comparator, changes over time or other influences cannot be separated from the intervention. The acute measurement timeframe also does not answer questions about sustained effects, weight change, or longer-term outcomes; those outcomes are not reported in the registry record.

The safety entries report 0 serious adverse events, 1 other adverse event, and 0 deaths. The record does not provide the event description or comparative evidence, so these figures should not be taken as a complete characterization of safety or causality. Overall, the registry documents a small acute challenge study and its intended measures, while the absence of reported outcome estimates prevents conclusions about the measured biological response.

14. Why This Trial Matters Statistically

This study illustrates the distinction between a clearly defined endpoint and a report of its result. The primary endpoint names the analyte, unit, summary measure, dispersion measure, and comparison interval: mean change in serum NAPE, measured in nmol/L, from baseline to 120 minutes, with standard error as the stated dispersion. That is enough to understand what the investigators intended to quantify. It is not enough to assess the magnitude or precision of the response when the estimate and its uncertainty are absent.

The design also matters statistically. A single-group baseline-to-follow-up study can describe within-participant change, but it lacks a concurrent comparator for separating the intervention from other explanations. This is a design limitation, not a problem that can be resolved simply by choosing a more elaborate analysis after data collection. The planned repeated blood draws make time-specific measurement possible, but the record does not report the model or analysis used for those measurements.

The record’s planning assumptions are another useful distinction. It describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, while identifying the illustration as separate from the trial’s own design. Planning calculations address hypothetical design choices; they are not observed power and cannot replace outcome estimates. The record does not report numerical planning values.

Finally, outcome reporting is central to statistical interpretation. Without estimates, uncertainty measures, analysis populations, or missing-data information, readers cannot judge precision, robustness, or how completely the endpoint was observed. The record is informative about the clinical question and measurement plan, but limited as evidence about the measured response.

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 main limitation for interpreting this trial is that the registry record does not report numerical results for the primary endpoint. The mean change in serum NAPE, standard error, confidence interval, and statistical test are not reported in the registry record. The same applies to the listed secondary outcomes and the glucose and subjective satiety measures mentioned in the summary. Thus, the planned measurements cannot be translated into an observed response or an assessment of its precision.

The single-group design has no separate control arm, and masking is listed as none. The study can be described as a baseline-to-post-oatmeal challenge, but a change over that interval would not by itself show that oatmeal caused it. The brief acute timeframe also does not address longer-term response. The registry record does not report participant characteristics in enough detail to assess how applicable the findings might be to a particular population. Although obesity and cardiovascular diseases are listed as conditions, the record does not say that all participants had either condition.

Enrollment is listed as 10, but the number contributing data to each outcome is not reported in the registry record. Missingness, exclusions, protocol deviations, outcome-specific analysis populations, and missing-data methods are also not reported. No statistical analysis is listed, and the registry record does not describe covariate adjustment, the handling of repeated measurements, or a multiplicity strategy. These gaps prevent evaluation of the analysis and its assumptions.

The safety entries provide counts but no event descriptions or assessment of relatedness. The record also does not report the rationale for enrollment, a sample-size justification for the actual single-group design, or whether interim analyses were conducted. These limitations concern what can be established from the registry record; they do not establish that the unreported information was absent from study conduct.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Oatmeal Effect on N-acyl-phosphatidylethanolamines — NCT03468179.
• Registry record last updated 2019-12-13; status last verified 2019-11.
• Results first posted 2019-12-13.
• 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

NCT03468179, titled “Oatmeal Effect on N-acyl-phosphatidylethanolamines,” is recorded as a completed, single-group study sponsored by Vanderbilt University Medical Center. Enrollment is listed as 10. The recorded start date is 2018-10-07, and the primary completion date is 2018-12-31. Phase and allocation are listed as NA, and masking is listed as none.

Participants were to arrive fasting, provide a baseline blood sample, receive oatmeal described as 80gm/100kg, and have blood drawn at 30, 60, 90, and 120 minutes. The primary endpoint is mean change in serum NAPE from baseline to 120 minutes, with standard error as the stated dispersion. Serum NAE is listed as a secondary outcome. The registry record does not report numerical outcome results or the statistical analysis.

The safety entries list 0 serious adverse events, 1 other adverse event, and 0 deaths. A separate control group is not listed.