This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders (NCT05382702), a randomized na study. The primary outcome is Subjective Rating of Fear.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05382702 |
| Phase | NA |
| Condition | Feeding and Eating Disorders |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 133 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ohio University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with feeding and eating disorders. The registry reports that 75 people completed both test meal visits; analyses of fear included 68 individuals. The record describes exclusions from the fear analyses, so the analysis population is narrower than the group reported to have completed both visits.
Intervention
At one visit, participants ate yogurt described as “high fat.” The study’s intervention is listed as a change in the test meal description. The registry does not specify the yogurt’s actual fat content or report other details about the meal beyond these descriptions.
Comparator
The comparison is with yogurt described as “low fat.” Participants were assigned to one of two orders: high-fat description at Study Visit 2 followed by low-fat description at Study Visit 3, or the reverse order. This is a crossover arrangement, in which participants encounter both descriptions.
Primary question
The registered primary outcome is subjective fear, measured with visual analogue ratings before and after the meal and summarized as area under the curve with respect to increase. The study asks whether fear ratings change across the meal period under the test meal conditions. Numerical results comparing the conditions, and the statistical evidence for any difference, are not reported in the registry record.
3. Trial Design
This is a randomized, single-masked crossover study listed as completed. The registry reports enrollment of 133 and gives the study dates as 2022-04-22 for the start and 2025-03-20 for primary completion. The phase is listed as NA. Ohio University is named as the sponsor.
The two registered sequences differ in the order of the meal descriptions. In one sequence, participants ate yogurt described as “high fat” at Study Visit 2 and yogurt described as “low fat” at Study Visit 3. In the other, the descriptions were reversed. Thus, the design exposes participants to both descriptions, with randomized order. The registry identifies the intervention as a change to the test meal description; it does not establish from these details whether the foods differed in actual fat content.
In a crossover design, each participant can contribute observations under both conditions. General statistical context: this can make within-person comparisons informative because measurements from the same person may be more alike than measurements from different people. At the same time, the sequence and timing of conditions matter. Period effects, order effects, or carryover from an earlier visit can affect interpretation if present. Whether the analysis addressed these issues is not reported in the registry record.
The study’s brief summary describes its aims as testing fear, gut peptide response, and perceptions of fullness as possible causes of gastrointestinal distress and eating disorder maintenance. That summary describes the research rationale; it is not evidence that any proposed mechanism was established. Numerical primary-outcome findings 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: Participants were assessed for potential eligibility via an online screening survey and phone screen. They then completed diagnostic interviews and questionnaires to confirm eligibility. If eligible, participants were then randomized to test meal condition order.
Study Visit 2 (First Test Meal)
| Stage | High Fat Yogurt - Low Fat Yogurt | Low Fat Yogurt - High Fat Yogurt |
|---|---|---|
| STARTED | 54 | 45 |
| COMPLETED | 47 | 40 |
| NOT COMPLETED | 7 | 5 |
Reasons for not completing this period:
| Reason | High Fat Yogurt - Low Fat Yogurt | Low Fat Yogurt - High Fat Yogurt |
|---|---|---|
| Withdrawal by Subject | 2 | 2 |
| Adverse Event | 1 | 0 |
| Lost to Follow-up | 4 | 3 |
Study Visit 3 (Second Test Meal)
| Stage | High Fat Yogurt - Low Fat Yogurt | Low Fat Yogurt - High Fat Yogurt |
|---|---|---|
| STARTED | 47 | 40 |
| COMPLETED | 40 | 35 |
| NOT COMPLETED | 7 | 5 |
Reasons for not completing this period:
| Reason | High Fat Yogurt - Low Fat Yogurt | Low Fat Yogurt - High Fat Yogurt |
|---|---|---|
| Adverse Event | 1 | 0 |
| Withdrawal by Subject | 1 | 2 |
| Lost to Follow-up | 4 | 3 |
| Experimenter error | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: In total, 75 people completed both test meal visits. However, only 68 individuals are included in the analyses of fear. We excluded the data of one participant whose responses suggested she did not attend to item content and the data of 5 individuals who failed to eat at least 85% of the yogurt test meal at any visit. One participant's self report data was missing at the -10 minute mark and so AUCi could not be calculated.
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: All randomized participants are reported for baseline analyses.
| Characteristic | Unit | High Fat Yogurt - Low Fat Yogurt | Low Fat Yogurt - High Fat Yogurt | Total |
|---|---|---|---|---|
| Participants analysed | 54 | 45 | 99 | |
| Age, Continuous | age in years | 19.76 (SD 2.874) | 20.27 (SD 3.557) | 19.99 (SD 3.196) |
| Sex: Female, Male: Female | Participants | 54 | 45 | 99 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 48 | 39 | 87 |
| Race (NIH/OMB): More than one race | Participants | 3 | 5 | 8 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 2 | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 51 | 43 | 94 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Trait gastrointestinal distress | Scores on scale | 2.64 (SD .708) | 2.58 (SD .723) | 2.61 (SD .712) |
6. Primary Endpoint
The registry lists the primary outcome as Subjective Rating of Fear, measured over -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on scale*minutes |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is subjective rating of fear, expressed in units on scale*minutes. Participants rated momentary fear on a visual analogue scale ranging from “Not at All (0)” to “Extreme (100).” Ratings were taken at -10 minutes, 0 minutes, immediately after the intervention, and 10 minutes post-intervention, as specified in the registry’s timeframe.
The registry describes an area-under-the-curve-with-respect-to-increase (AUCi) summary. Its stated formula uses ratings at -10 minutes, 0 minutes, and +10 minutes. A more positive AUCi indicates greater increases in fear over the pre-to-post meal period. The summary therefore represents change across the measurement interval, rather than a single rating at one time point.
General statistical context: an area-under-the-curve measure combines repeated observations over time into a single summary. This can capture the overall pattern of change while reducing a series of measurements to an endpoint that can be compared across conditions. The registry specifies the mean as the parameter and standard deviation as the dispersion measure. The reason this endpoint was selected, beyond its connection to the study’s stated interest in fear around eating, is not reported in the registry record. Numerical endpoint results are also not reported there, so the direction and magnitude of observed fear changes cannot be assessed from the available record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines the primary outcome and identifies the population included in its fear analyses, but it does not report the numerical outcome estimates. It therefore does not establish how fear ratings changed over the meal period, whether the two meal-description conditions differed, or how precisely any difference was estimated. No primary-outcome means, standard deviations, confidence intervals, or p-values are reported in the registry record.
The design is randomized and crossover: participants were assigned to a sequence and encountered both meal descriptions. This makes the within-person contrast central to understanding the study question. However, the registry information available for this analysis does not give the actual contrast, the statistical model, or whether the analysis accounted for sequence, visit period, or possible carryover. Without those details and the outcome results, an effect estimate cannot be interpreted.
The record reports that 75 people completed both test meal visits and that 68 were included in the fear analyses. It says that one participant’s responses suggested she did not attend to item content and that data from 5 individuals who failed to eat at least 85% of the yogurt test were excluded. These details describe the analysis population; they do not reveal whether the exclusions affected the result or whether other missing observations occurred.
General statistical context: an estimate describes the observed contrast, while a confidence interval describes the range of values compatible with the data and the analysis assumptions. A p-value, when reported, addresses how compatible the data are with a specified null hypothesis under those assumptions. Neither a p-value nor a confidence interval alone establishes clinical importance. Here, these quantities and the underlying estimates are not reported in the registry record.
The record lists 7 outcome measures and 7 analyses, but does not report a multiplicity strategy. When several outcomes or comparisons are examined, the chance of a seemingly notable finding can be affected by how many tests are considered and how they are related. Without the analysis plan and results, it is not possible to determine how this issue was handled. The available information supports a description of the design and endpoint, not a conclusion about the observed effect.
9. Statistical Methods Explained
The registry specifies a continuous primary outcome summarized as a mean with standard deviation. The fear measure is not a single post-meal rating: it uses repeated visual analogue ratings and an AUCi summary. The registered scale runs from “Not at All (0)” to “Extreme (100),” and the endpoint is expressed in units on scale*minutes. The record’s formula combines measurements at -10 minutes, 0 minutes, and +10 minutes. It states that more positive values indicate greater increases in fear over the pre-to-post meal period.
What does an area-under-the-curve summary represent?
General statistical context: an area-under-the-curve summary combines measurements taken at different times, taking account of the interval between observations. AUCi is intended to describe increase relative to the starting measurement, rather than simply the total area under the curve. In this study’s registered definition, the score reflects the trajectory across the measurement period. It condenses repeated ratings into a continuous outcome that can be summarized across participants and compared between conditions.
The registry describes the time frame as -10 minutes, 0 minutes (immediately after the intervention), and 10 minutes post-intervention. Its written endpoint description refers to changes from the period prior to the meal until immediately after the meal, while the stated formula also includes the +10-minute rating. This is a detail worth noting when interpreting the endpoint definition. The formula, rather than an assumed alternative time window, is the specific calculation recorded.
Why does the crossover structure matter?
General statistical context: crossover studies compare conditions experienced by the same participants. This can account for stable differences between people when the analysis uses within-person contrasts. But the observations are not independent in the same way as measurements from unrelated participants. The analysis should reflect the pairing and may also need to account for sequence or visit period, depending on the design and assumptions. An earlier condition could also influence a later measurement; this is commonly described as carryover.
The registry establishes the randomized order and crossover model, but does not report the statistical model used for the primary outcome or whether period, sequence, or carryover were assessed. The specific approach to handling the paired measurements is therefore not reported in the registry record. The record also does not report whether investigators used adjusted or unadjusted estimates.
What do the mean and standard deviation communicate?
General statistical context: a mean describes the average outcome in a group or condition. A standard deviation describes the spread of individual observations around that mean. These answer different questions: the mean concerns the central value, while the standard deviation concerns variability among observations. Neither quantity, by itself, gives the precision of a comparison between conditions. That assessment generally requires an uncertainty measure for the contrast, such as a confidence interval. No numerical means, standard deviations, or contrast estimates for the primary endpoint are reported in the registry record.
The registry’s sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence of achieved power or a report of the trial’s own design rationale. No numerical planning results are present in the record available for this analysis. The study’s original sample-size justification is not reported in the registry record.
General statistical context: a planning calculation estimates the sample size that might be needed under specified assumptions. It does not show that a completed study had a particular probability of detecting an effect, and it does not substitute for the observed estimate and its uncertainty. Sample-size illustrations based on an observed effect are especially dependent on that effect estimate and the assumptions used. They should not be interpreted as observed power.
Overall, the methods information gives a useful operational definition of the primary endpoint and identifies the crossover arrangement. It does not provide enough detail to reproduce the primary analysis or assess its inferential results. The statistical model, treatment contrast, confidence interval method, and p-value method are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures and 7 analyses. It does not report how the primary outcome was distinguished analytically from the other outcomes, whether there were multiple comparisons for any outcome, or whether a multiplicity adjustment or other strategy was planned. The statistical analysis plan is not reported in the registry record.
General statistical context: testing multiple outcomes or contrasts can increase the opportunity for apparently notable results by chance. The implications depend on how many tests were conducted, which were prespecified, how outcomes are related, and what adjustment strategy was used. The number of listed outcomes and analyses alone does not establish that a particular adjustment was necessary or applied. Without the analysis plan and complete results, multiplicity cannot be evaluated.
The fear analysis population is described as 68 individuals, while 75 people are reported to have completed both test meal visits. The record states that data from one participant were excluded because responses suggested she did not attend to item content, and data from 5 individuals were excluded because they failed to eat at least 85% of the yogurt test. It does not report how missing ratings were handled, whether any other observations were missing, or whether sensitivity analyses assessed the effect of the exclusions.
The registry does not report an intention-to-treat analysis, a per-protocol analysis definition, or a prespecified rule for inclusion in the fear analysis. The stated exclusions provide some information about who was not included, but do not describe the full analysis-population policy. Whether all randomized participants contributed to other outcomes is not reported in the registry record. These gaps limit assessment of potential bias from missing data, exclusions, and analytic choices.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| High Fat Yogurt | 0 | 99 | 0.0% |
| Low Fat Yogurt | 0 | 99 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| High Fat Yogurt | 0 of 99 |
| Low Fat Yogurt | 0 of 99 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| High Fat Yogurt | 8 of 83 |
| Low Fat Yogurt | 4 of 82 |
Most frequent non-serious adverse event terms
| Event term | Organ system | High Fat Yogurt | Low Fat Yogurt |
|---|---|---|---|
| Vasovagal Response to IV Insertion | General disorders | 8 of 83 | 4 of 82 |
The registry reports serious adverse events separately for the High Fat Yogurt and Low Fat Yogurt groups. It records 0 serious events in each group, with 99 at risk in each. Deaths are recorded as 0 in both groups. The record lists 8 other events among 83 at risk in the High Fat Yogurt group and 4 other events among 82 at risk in the Low Fat Yogurt group.
These are registry-reported event counts and at-risk counts; they should be read as such, rather than as a complete account of individual experiences. The record does not provide serious-event terms, and it does not list which types of other events occurred. It also does not explain the difference between the at-risk counts for other events and those for serious events. The registry’s event figures do not establish that an event was caused by a meal description or that the groups are directly comparable for safety.
General statistical context: small event counts can be imprecise, and the interpretation of safety comparisons depends on follow-up, event definitions, exposure, and how events were collected. Those details are not reported in the registry record. The listed counts alone do not support a broader safety conclusion.
12. What the Result Does, and Does Not, Mean
This record supports a description of a randomized crossover study in which participants encountered yogurt described as “high fat” and “low fat” in different orders. It also defines subjective fear as the primary outcome and gives the AUCi calculation used to summarize ratings across the meal period. These details clarify what the study was designed to examine, but they are not the observed primary result.
The numerical results for subjective fear are not reported in the registry record. As a result, the available information cannot show whether ratings increased or decreased under either description, whether there was a difference between conditions, or how precise a comparison might be. It cannot establish the size or practical importance of any effect. The same limits apply to the study’s broader aims concerning gut peptide response, fullness, gastrointestinal distress, and eating disorder maintenance: the brief summary states the research rationale, but the outcome findings needed to evaluate those aims are not reported.
The registry identifies 75 people as having completed both test meal visits and 68 as included in the fear analyses. It also describes exclusions based on response quality and the amount of yogurt eaten. These registry entries help define the population represented by the fear analysis, but they do not show whether the findings would differ under another analysis population.
General statistical context: a randomized design can support a structured comparison, but a design label alone does not establish a result. Interpretation depends on the outcome estimates, uncertainty, analysis methods, and the degree to which the analysis follows the intended design. Because those numerical findings and key analytic details are not reported in the registry record, conclusions about the direction, magnitude, or certainty of an effect are not warranted from the available information.
13. Why This Trial Matters Statistically
This trial is statistically notable for combining randomized order with a crossover design and a subjective outcome measured repeatedly around a meal. That structure creates a within-person question: how do fear ratings, summarized across time, compare when the meal is described in different ways? The registered endpoint makes the timing and direction of the summary relevant to interpretation.
The study also illustrates why an outcome definition and an outcome result are not interchangeable. The record gives a specific visual analogue scale, AUCi formula, and analysis population. Those details allow readers to understand what was intended to be measured. But without the numerical estimates and uncertainty, they do not reveal the observed contrast or its precision.
General statistical context: crossover designs can reduce the influence of stable differences between participants when comparisons are appropriately paired. They also require attention to period, order, and potential carryover. Clear reporting of the statistical model and of how the analysis handled the repeated observations is important for evaluating whether the estimate matches the design. Those analytic details are not reported in the registry record.
The record’s description of exclusions also highlights a broader interpretive issue: the population analyzed may not be identical to everyone who completed the visits. Reporting who contributed data, why observations were excluded, and how missing data were addressed helps readers assess the scope of an estimate. Here, the record gives some exclusion details but not a full missing-data or analysis-population plan.
Finally, a study aimed at mechanisms of gastrointestinal distress and eating disorder maintenance can raise several related statistical questions across outcomes. The registry lists multiple outcomes and analyses, but does not report how multiplicity was addressed. Together, the endpoint definition, crossover structure, and incomplete reporting of results make this record a useful example of why statistical interpretation requires both design information and transparent results.
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.
The principal limitation for interpreting the primary endpoint is that numerical fear results are not reported in the registry record. There are no reported condition-specific means or standard deviations, contrast estimates, confidence intervals, or p-values in the available information. The direction, magnitude, and precision of the primary comparison therefore cannot be assessed.
The record identifies a randomized crossover design and gives the order of the meal descriptions, but does not report the statistical model used to analyze the repeated observations. It is not reported whether the analysis accounted for pairing, sequence, visit period, or carryover. The intervention is described as a change in test meal description, but the registry does not state the actual fat content of the yogurt or provide further meal details.
The registered timeframe and formula merit careful reading: the timeframe names -10 minutes, 0 minutes, and 10 minutes post-intervention, while the formula also explicitly incorporates the +10-minute rating. The endpoint description refers to changes until immediately after the meal. The record does not explain this wording, so the formula is the clearest statement of how the AUCi was calculated.
The fear analysis included 68 individuals, compared with 75 reported to have completed both visits. Exclusion reasons are given for one participant and 5 individuals, but other missing-data details and sensitivity analyses are not reported. The record also does not report a multiplicity plan despite listing 7 outcome measures and 7 analyses. These limitations constrain evaluation of bias, precision, and the robustness of any conclusion.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders — NCT05382702.
- Registry record last updated 2026-04-15; status last verified 2025-01.
- Results first posted 2026-04-15.
- 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.
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18. Record Summary
The registry identifies NCT05382702 as a completed randomized, single-masked crossover study sponsored by Ohio University. Enrollment is listed as 133, with a start date of 2022-04-22 and primary completion date of 2025-03-20. The study concerns feeding and eating disorders and compares the order of yogurt descriptions: “high fat” and “low fat.”
The primary outcome is subjective fear, summarized as AUCi from repeated visual analogue ratings around the meal. The registry reports that 75 people completed both visits and 68 were included in the fear analyses, with stated exclusions. Numerical primary-outcome findings and key details of the statistical analysis are not reported in the registry record. The event counts are recorded separately for the two meal-description groups.