Shifting Salty Taste Preferences in Children: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Shifting Salty Taste Preferences in Children (NCT02909764), a randomized na study. The primary outcome is Most Preferred Level of Salt Taste.

2. Clinical Question

The underlying research goals also included examining whether changes in preference were related to dietary salt intake, taste receptor genotype, and anthropometric and physiological measures. These are stated as goals, not as findings. The listed secondary outcomes include salt taste detection thresholds, most preferred level of sucrose, cereal intake during the intervention period, and blood pressure. No results for those measures are reported in the registry record.

The clinical question is therefore about a behavioral taste preference measured with broth samples, rather than a reported clinical event or a direct measure of health benefit. The record describes the intended comparison and measurement process, but does not establish whether the groups differed, how large any difference was, or how precisely it was estimated.

3. Trial Design

The registry describes a randomized, triple-masked, parallel-group study sponsored by Monell Chemical Senses Center. Its status is completed. The recorded study start is 2016-01 and primary completion is 2016-08. Enrollment is listed as 39. The registry does not identify which people or roles were masked, or explain how randomization and masking were implemented.

The parallel design assigns participants to one of two groups: a Control Group receiving regularly salted cereal, or a Low Sodium Group receiving low-sodium cereal. Both descriptions specify consumption 4 times per week over a 2-month period. The registry record does not report further details about adherence monitoring, the cereal composition, or whether other aspects of participants' diets were controlled.

The primary outcome is most preferred level of salt taste, assessed at baseline and after the 8-week intervention. Children tasted pairs of broths at different salt concentrations and selected the one they liked better. The registry describes a sequential pairing task and says that the task was repeated with the stimulus pairs presented in reverse order. The geometric mean of the two series' selected concentrations was used to determine the preferred level.

The registry lists six outcome measures and six analyses. It also identifies several outcome categories or time points that were not reduced to one comparison. Specific analysis methods, the analysis population, and the handling of missing measurements are not reported in the registry record. The phase is listed as NA, and the condition is listed as Development; neither entry supplies additional detail about the study population or clinical setting.

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: Children were randomized at the beginning of the first test session. There were no significant effects that occurred after participant enrollment but before randomization to study group.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Some children did not understand the task and responded at random.

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 Most Preferred Level of Salt Taste, measured over Baseline (time 0) and after 8-week intervention.

The primary endpoint is the most preferred level of salt taste, expressed in mol/L as a geometric mean with standard error. It was measured at baseline and after the 8-week intervention. A preference task can describe which salt concentration a participant favors among the tested samples; it does not, by itself, measure total dietary sodium intake or a health outcome.

Children tasted broth samples in pairs. The registry lists concentrations of 0.16, 0.24, 0.38, 0.61, and 1.05 M. The first pair used concentrations from the middle of the range. Participants selected the sample they liked better, and subsequent pairs used the selected concentration alongside an adjacent concentration. The task continued until the selection pattern met one of the stopping descriptions in the registry. The task was then repeated with the pairs presented in reverse order, and the geometric mean of the two chosen concentrations was used as the preferred level.

Using the geometric mean combines the selections from the two series into one measure, as described in the record. The standard error characterizes uncertainty in an estimated mean rather than the spread of individual preferences. In general, a preference endpoint can help describe the measured taste response, but its interpretation depends on reliable task performance. The record specifically notes that some children responded at random because they did not understand the task. It does not report how these observations were handled or provide the endpoint results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, triple-masked, parallel design. In general, random allocation is intended to make comparison groups less subject to systematic differences at assignment, while masking can reduce some forms of biased behavior or assessment. The record does not say how the random sequence was generated, how allocation was concealed, who was masked, or whether masking was maintained. Those implementation details are not reported in the registry record, so the design labels alone cannot establish how well those protections operated.

What does the endpoint summarize?

The outcome is a geometric mean of concentrations selected in two taste-testing series. In general, a geometric mean summarizes positive measurements on a multiplicative scale and can be useful when the scale and distribution make that summary appropriate. The registry identifies the statistic, but does not report the analysis scale beyond the stated mol/L unit, the distribution of individual values, or the reason this summary was chosen. The method should therefore be understood as the recorded summary measure, not as evidence about the shape of the outcome distribution.

The registry reports standard error as the dispersion measure. In general, a standard error describes the estimated uncertainty of a statistic, such as a mean, and is not the same as a standard deviation describing variation among individual observations. A standard error is most informative when read with the estimate and the method used to calculate it. The outcome estimates and standard errors are not reported in the registry record, so their magnitudes cannot be interpreted.

How should uncertainty be understood?

In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates more uncertainty. A p-value, when reported, addresses compatibility between observed data and a specified null model; it does not measure the size or clinical importance of an effect. The registry record does not report a confidence interval, p-value, or other inferential result for the primary outcome. No conclusion about statistical significance or precision can be drawn without those results.

The record describes the primary outcome at baseline and after the 8-week intervention, but the outcome is not reduced to one comparison because there are several categories or time points. A comparison could be framed in more than one way, such as comparing post-intervention values or comparing changes from baseline, but the registry does not identify which contrast was used. Those approaches are not interchangeable in every analysis, and the intended primary contrast is not reported in the registry record. No specific test, model, covariate adjustment, or repeated-measures method is described.

Why does task performance matter?

The preference task uses adaptive pairings: each later pair depends on a participant's earlier selection. In general, the validity of an adaptive measurement depends on participants understanding and following the task. The registry explicitly notes that some children did not understand it and responded at random. That is evidence of a possible measurement-quality issue, but the record does not report how often this occurred or what rules were used to identify such responses. It also does not explain whether the two series were combined for every participant or how incomplete tasks were handled.

The stated standard error does not resolve these questions. Precision of a summary can be affected by the number of usable observations and by variability in responses, while non-understanding can affect the meaning of those responses. The analysis population, missing data, and treatment of random responding are not reported in the registry record. It is therefore not possible to judge whether the reported measure, if available elsewhere, would represent all randomized participants or a subset with interpretable task performance.

What do the planning assumptions mean?

The record describes sample-size illustrations as planning calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is specified as a stated fraction of the observed effect. Such calculations are hypothetical planning tools: they indicate the number of participants per arm that would be needed under those assumptions, rather than describing what the completed trial was powered to detect. These planning illustrations are never observed power.

In general, sample-size calculations depend on assumptions about the effect to detect, variability, significance level, allocation, and statistical method. Changing an assumption can change the calculated planning requirement. The registry record does not report the trial's own sample-size justification or its original design assumptions. The illustration assumptions should not be mistaken for a documented protocol plan. Nor do planning values establish whether an observed result is reliable: that requires the actual outcome estimate, uncertainty, and analysis details.

The registry lists six outcome measures and six analyses. It does not specify a statistical testing hierarchy, a multiplicity adjustment, or which analysis is considered confirmatory. General statistical practice recognizes that testing multiple outcomes or contrasts can increase the chance of at least one apparently unusual result under a null model. Whether and how that issue was addressed in this study is not reported in the registry record. The presence of multiple listed analyses alone does not reveal the procedures used.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and six analyses. The primary endpoint is recorded at baseline and after the 8-week intervention, and the registry indicates that its several categories or time points were not reduced to one comparison. This leaves the primary contrast unclear in the record. It does not say whether the main question was a between-group difference at follow-up, a comparison of changes, or another prespecified summary.

When several outcomes, time points, or contrasts are analyzed, multiplicity can affect how inferential results should be interpreted. In general, testing multiple hypotheses may increase the chance of observing at least one result that appears statistically notable by chance. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a plan distinguishing primary from exploratory analyses. That absence does not show that no such procedures existed; it means they are not reported in the registry record.

The listed secondary outcomes are salt taste detection thresholds, most preferred level of sucrose, intake of cereal during the intervention period, and blood pressure. The record does not provide their estimates or describe how those outcomes were analyzed. Although the registry lists six outcome measures and six analyses, it does not map the analyses to specific outcome contrasts in the information recorded.

The analysis population is not reported in the registry record. It is not stated whether analyses followed randomized assignment, included only participants with completed taste tasks, or used another population definition. The record notes that some children did not understand the task and responded at random, but does not explain how those responses were treated. Missing measurements, reasons for missingness, and any imputation or sensitivity analyses are also not reported. These omissions limit interpretation of both the primary endpoint and the secondary outcomes.

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 adverse-event record lists the Control Group [Regular Sodium Group] with 19 participants at risk for serious adverse events and 0 affected, and 19 at risk for other adverse events and 0 affected. The Low Sodium Group has 20 participants at risk for serious adverse events and 0 affected, and 20 at risk for other adverse events and 0 affected. Deaths are listed as 0 in each group. These are the registry's recorded counts; they should not be read as proof that no adverse events occurred outside the information captured in this record.

In general, a zero count means that no events of the specified type are recorded among the stated participants at risk. It does not establish that the underlying risk is zero, and it does not show how completely events were sought or reported. The registry does not provide further information about adverse-event definitions, surveillance methods, duration of safety follow-up, or event severity beyond the serious and other categories displayed. No serious adverse-event terms are listed.

The listed at-risk counts are safety denominators, not necessarily the analysis population for the primary endpoint. The registry does not report how many children contributed usable preference measurements or how safety follow-up related to endpoint follow-up. These figures describe the adverse-event entries in the record and should be interpreted separately from the unreported taste-preference results.

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

The study addresses whether repeated exposure to low-sodium cereal is associated with a change in children's preferred salt taste level. The registry records randomized assignment to low-sodium or regularly salted cereal, a parallel-group design, and a preference assessment at baseline and after the 8-week intervention. This identifies the research question and how the primary measure was intended to be collected.

The record does not report primary outcome values, a between-group estimate, or a measure of uncertainty. It therefore does not show whether preferred salt taste changed, whether the groups differed, or how precisely any difference was estimated. It also does not report results for the listed secondary outcomes. No conclusion about the direction, magnitude, statistical evidence, or health implications of the intervention can be drawn from the outcome information in this registry record.

Even if a difference in the preference measure were reported, that measure would address preference among broth samples at specified salt concentrations. It would not automatically establish a change in overall dietary salt intake, blood pressure, or another health outcome. The registry's broader research goals mention relationships with salt intake, taste receptor genotype, and anthropometric and physiological measures, but the record does not report findings on those questions.

The note that some children responded at random because they did not understand the task is an additional reason to interpret the endpoint with attention to measurement quality. The registry does not report how these responses were handled or how many measurements were considered usable. Without that information, the relationship between the recorded task and children's underlying preferences cannot be assessed from this entry.

The completed status and enrollment entry describe the study record, but do not substitute for outcome reporting. The posted information can support a description of the design, intervention schedule, endpoint, and recorded adverse-event counts. It cannot establish that the intervention did or did not produce a particular effect, nor can it support medical advice.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its primary outcome is a preference measured through an adaptive task rather than a simple fixed questionnaire item. A participant's later broth pair depends on earlier choices, and the recorded endpoint combines selections from the task and its reverse-order repetition. That measurement process makes understanding the task and applying consistent rules important to the interpretation of the final summary.

The registry directly flags a challenge: some children did not understand the task and responded at random. That raises questions about the definition of a usable measurement, how such responses were recognized, and whether they were included in analysis. The registry record does not report the answers to those questions. This illustrates a broader statistical principle: even a carefully defined summary measure cannot compensate for uncertainty about whether the underlying observations measure what they are intended to measure.

The study also has a baseline and post-intervention assessment, while the record does not reduce the endpoint to one comparison. For repeated assessments, the choice of contrast affects the interpretation. A post-intervention group comparison and a comparison of changes from baseline answer related but distinct questions. The record's failure to specify a single contrast prevents readers from identifying the primary estimand from the information recorded.

Finally, multiple outcome measures and analyses are listed, but no statistical analysis plan or multiplicity procedure is reported. This makes it difficult to distinguish a planned primary test from additional analyses. The example underscores why clear reporting of estimands, analysis populations, handling of problematic observations, uncertainty, and multiplicity can be as important as describing randomization and masking. Here, those details are not reported in the registry record.

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 specific to this trial are visible in the registry record. The primary outcome task required children to compare paired broths, make sequential selections, and repeat the task in reverse order. The record states that some children did not understand the task and responded at random. It does not report how comprehension was assessed, how random responding was identified, or how affected observations were handled. This leaves uncertainty about the quality and inclusion of endpoint measurements.

The endpoint is assessed at baseline and after the 8-week intervention, but the registry indicates it was not reduced to one comparison because of several categories or time points. The primary group contrast is consequently not clear from the record. Specific statistical methods, an analysis population, missing-data procedures, and handling of repeated measurements are not reported. The results for the primary endpoint and the listed secondary outcomes are also not reported in the registry record.

Details needed to evaluate implementation are limited. The record identifies randomization, triple masking, and a parallel design, but does not report the randomization method, allocation concealment, the people or roles masked, or whether masking was maintained. It describes cereal consumption 4 times per week over a 2-month period, but does not report adherence or further intervention details.

The registry lists enrollment as 39, but does not provide a participant flow or explain how many children contributed to each outcome analysis. It also does not report eligibility criteria, ages, or relevant baseline characteristics. Safety entries list zero affected participants in the reported categories, but methods and duration of adverse-event ascertainment are not described. These limitations concern what is recorded; they do not establish that the unreported procedures or information were absent from the study itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Shifting Salty Taste Preferences in Children — NCT02909764.
• Registry record last updated 2019-09-30; status last verified 2019-09.
• Results first posted 2019-08-20.
• 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 describes a completed randomized, triple-masked, parallel-group study sponsored by Monell Chemical Senses Center, with enrollment of 39. The study compared low-sodium cereal with regularly salted cereal, consumed 4 times per week over a 2-month period.

The primary outcome was most preferred level of salt taste, assessed at baseline and after the 8-week intervention using paired broth tastings. The record notes that some children did not understand the task and responded at random. It lists secondary outcomes including salt taste detection thresholds, most preferred level of sucrose, cereal intake during the intervention period, and blood pressure.

Primary and secondary outcome results, the primary group contrast, analysis methods, missing-data procedures, and analysis populations are not reported in the registry record. The adverse-event entries record 0 serious and 0 other adverse events in each group, and deaths of 0 in each group.