Multicultural Healthy Diet in Chronic Kidney Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multicultural Healthy Diet in Chronic Kidney Disease (NCT05504850), a na na study. The primary outcome is Feasibility of Dietary Intervention.

2. Clinical Question

3. Trial Design

This completed pilot intervention study enrolled 18 participants with chronic kidney disease. It is recorded as a single-group study in which all participants received the Multicultural Health Diet intervention. The registry lists allocation as NA and masking as none. There is no randomized or concurrent control group described, so the design is not a like-for-like comparison of intervention and control arms.

The study’s stated aim was to evaluate the feasibility and acceptability of a culturally tailored anti-inflammatory diet intervention. The official title specifies racial and ethnic minorities with chronic kidney disease, while the registry’s condition is chronic kidney disease. Further eligibility criteria and participant characteristics are not reported in the registry record.

The primary outcome timeframe runs from baseline before intervention to 2 months after intervention. The record identifies the Automated Self-Administered 24-hour Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index as assessment tools. It describes the primary outcome as a score on a scale, summarized by a mean with a 95% confidence interval. The actual primary outcome estimate and interval are not reported in the registry record.

The study is marked completed, with a start date of 2022-11-03 and primary completion date of 2024-12-31. The phase is listed as NA. The registry record does not report a sample-size justification, a detailed statistical analysis plan, or further information about intervention delivery. The single-group structure and absence of masking are important when interpreting any changes that might be measured over time: without a control group, changes cannot be separated from other influences as they could be in a randomized comparison.

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: All 18 participants who were consented were enrolled into the study.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Baseline data and information provided for the 17 participants who completed the study.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of Dietary Intervention, measured over From baseline (pre-intervention) to 2 months (post-intervention).

The primary endpoint is listed as feasibility of the dietary intervention, measured as a score on a scale and summarized using a mean and 95% confidence interval. Its timeframe is from baseline before intervention to 2 months after intervention. The registry identifies the Automated Self-Administered 24-hour Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index as assessment tools. The former supports self-administered dietary recalls or food records; the latter quantifies the inflammatory potential of a diet while adjusting for total energy intake.

The Energy-Adjusted Dietary Inflammatory Index is described as ranging from -8.87, maximally anti-inflammatory, to +7.98, maximally pro-inflammatory. Higher positive scores indicate greater adherence to a pro-inflammatory dietary pattern, while lower negative scores indicate greater adherence to an anti-inflammatory pattern. These descriptions explain the direction of the scale; they do not establish what participants scored. The observed scores, mean, and confidence interval are not reported in the registry record.

Feasibility measures are used in pilot studies to assess whether an intervention and its measurement procedures can be carried out. They are distinct from evidence of a comparative treatment effect. The registry record does not report how feasibility was operationalized, what threshold would count as feasible, or a numerical acceptability outcome. Therefore, the stated purpose and tools can be described, but the primary endpoint result cannot be interpreted from the posted registry information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is described as a continuous score, with the mean and 95% confidence interval specified as its summary. The registry record does not report the numerical estimate or interval, nor does it provide a detailed account of the statistical procedures used. The distinction between a named summary and a reported result is important: knowing that a mean and interval were planned does not reveal the score observed in the study.

What does a mean describe?

In general, the mean is a measure of the center of a set of numerical observations. It can offer a concise description of scores, but it does not show how individual participants’ values vary. The mean’s interpretation depends on what was measured, when it was measured, and whether it represents one time point or a change over time. The registry specifies a baseline-to-2-month timeframe, but the actual values and the precise contrast used to summarize that timeframe are not reported in the registry record.

What does a confidence interval convey?

In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval does not by itself establish clinical importance or eliminate possible bias. Here, the registry identifies a 95% confidence interval as the dispersion measure but does not report its endpoints. Its precision therefore cannot be assessed from the posted outcome information.

How does the design affect the analysis?

This is a single-group study, with all participants receiving the intervention and no control group. A baseline and follow-up assessment in the same participants would ordinarily involve related observations, rather than independent groups. In general, analyses of repeated measurements need to account for that relationship. The registry record does not report whether the primary analysis used paired differences, a model for repeated measurements, or another approach. It also does not specify whether the endpoint was analyzed as a follow-up score, a change score, or in another way.

In general, over-dispersion means that observed variability is greater than a model assumes. When that occurs, model-based uncertainty can be understated if the extra variability is ignored. The registry record does not report a dispersion assessment or a model that would permit determining whether over-dispersion was relevant to this score. No particular distributional assumption or diagnostic procedure should be inferred from the listed mean and confidence interval alone.

What can a planning calculation establish?

In general, sample-size planning calculations estimate how many participants might be needed under stated assumptions to detect a target effect. They are not a substitute for observed outcomes and do not indicate the probability that the study’s result is true. The planning illustration associated with this record uses a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation; its target effect is expressed as a fraction of an observed effect. Those assumptions do not describe the actual single-group design, which has no two-arm allocation. Such calculations are planning illustrations, not evidence of observed power, and they are not the trial’s own sample-size justification. The registry record does not report the protocol’s sample-size justification.

The record identifies three outcome measures and one analysis, but does not give enough detail to reconstruct an analysis plan or determine how the listed outcomes relate to the primary analysis. The exact statistical test, any adjustment for baseline values or other covariates, the handling of incomplete observations, and the analysis population are not reported in the registry record. These details matter because different defensible methods can yield different estimates or uncertainty, particularly in a small pilot study. Without them and without the numerical outcome results, statistical precision and robustness cannot be evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists three outcome measures and one analysis. Those counts alone do not establish which measures were included in that analysis, which were primary or secondary, or whether any multiplicity adjustment was planned. The analysis plan and any approach to controlling the risk of false-positive findings across multiple outcomes are not reported in the registry record. Since the numerical outcome results are also not reported, there are no posted estimates or p-values on which to assess the implications of multiple testing.

Missing-data handling is another important part of interpreting a study with baseline and follow-up measurement. In general, if some participants do not contribute follow-up information, the analysis can depend on why observations are missing and on the method used to handle them. The registry record does not report how many participants contributed outcome data at either time point, whether any data were missing, or how missing observations were treated. It is therefore not possible to determine whether the stated enrollment of 18 is also the analyzed population for the primary outcome.

The registry record does not report a definition of the analysis population, such as whether all enrolled participants were included or whether inclusion depended on having measurements at both time points. It also does not report whether any sensitivity analysis was conducted. These omissions do not show that data were missing or that an analysis was inappropriate; they mean the posted record does not describe these aspects sufficiently to evaluate them. No assumptions about imputation, exclusion, or complete-case analysis should be inferred.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 18 participants at risk for serious adverse events and reports 0 serious adverse events. It also lists 18 participants at risk for other adverse events and reports 0 other adverse events. Deaths are listed as 0. No serious adverse event terms are listed in the record.

These are event counts in the posted safety record, not a comparison with another group. Because all participants received the intervention, the safety figures do not estimate a difference in adverse events between intervention and control. The registry record does not provide further details about the period of safety monitoring, event-collection procedures, or the completeness of reporting. The counts should be read as no events recorded in these categories in this registry entry, rather than as proof that an event could not occur or that risk is absent.

In general, zero observed events can still be compatible with uncertainty about the frequency of uncommon events, particularly when the number of participants is limited. The registry’s risk counts and event counts are useful for describing what was posted, but they do not establish a broader safety profile. The record does not report additional safety analyses or a comparative safety assessment.

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

The study record describes a completed pilot of a culturally tailored anti-inflammatory diet intervention in participants with chronic kidney disease. It identifies feasibility as the primary outcome, names dietary assessment tools, and sets a baseline-to-2-month timeframe. It also records enrollment of 18 participants and reports zero serious adverse events, zero other adverse events, and zero deaths in the listed safety categories.

However, the primary outcome values are not reported in the registry record. The mean and 95% confidence interval are named as the intended summary, but their numerical results are absent. Consequently, the posted record does not show the measured feasibility score, its precision, or whether scores changed from baseline to follow-up. It does not establish an acceptability finding, either. The study’s stated aim should not be mistaken for a reported outcome.

The design further sets limits on what the study could establish. Because it is single-group and has no randomized comparator, a change over time would not by itself distinguish an intervention effect from other explanations for change. The registry record does not report a comparative estimate. Its safety counts are descriptive and do not compare risks across groups.

In general, pilot studies can provide information about whether an intervention and its assessment approach are workable and can inform later research. This record documents that feasibility and acceptability were the intended focus, but the posted information does not supply the outcome findings needed to judge those questions. The record therefore supports a description of the study’s design and reported safety counts, not a conclusion about the dietary intervention’s effect or success.

13. Why This Trial Matters Statistically

This study is statistically notable because its central question is feasibility rather than a randomized comparison of treatment effects. Pilot studies often focus on whether an intervention and its measurement procedures can be implemented, while also producing descriptive estimates that may help plan later work. For those aims, clear reporting of recruitment, completion, acceptability, outcome summaries, and uncertainty is important. The registry record states the feasibility and acceptability purpose and names dietary assessment tools, but does not report the primary outcome values or an acceptability result.

The single-group structure is also important for statistical interpretation. With everyone receiving the intervention and no control group, the study does not estimate a randomized contrast. Any pre-to-post measurement would be informative as a within-group observation, but other changes over time could also contribute. Recognizing that design distinction prevents a descriptive pilot result from being read as stronger causal evidence than the design supports.

The registry’s stated summary, a mean with a 95% confidence interval, would ordinarily help readers assess both the score’s center and its precision. Here, the numerical estimate and interval are not reported in the registry record, so neither the magnitude nor precision of the primary result can be evaluated. The record also does not provide enough detail about missing data or analysis populations to assess how complete the outcome information was.

Finally, the safety counts illustrate why reporting counts and denominators matters, while also showing the limits of a small single-group record for assessing uncommon events. The posted zero counts are descriptive, not comparative evidence. Taken together, the design and reporting make this record useful for identifying the study’s question and approach, while leaving the main outcome findings unavailable for statistical assessment.

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.

Interpretation is limited first by the absence of numerical primary outcome results. Although the registry record specifies a mean and 95% confidence interval, neither is reported. A reader therefore cannot assess the observed score, its uncertainty, or change between baseline and 2 months. The stated aim includes acceptability, but a specific acceptability measure or result is not reported in the registry record.

The design is single-group, with no separate control arm and no masking. This limits causal interpretation: without a randomized comparison, a measured change over time could not be attributed to the intervention alone. The enrollment of 18 participants also means the study is a small pilot, and the registry does not report a sample-size justification. No conclusion about statistical power or the precision of any unposted estimate can be drawn.

The registry identifies the outcome tools and timeframe, but does not report the exact statistical analysis, the analysis population, participant counts at each measurement time, or how missing observations were handled. It does not provide participant characteristics beyond the chronic kidney disease condition and the population description in the official title. The intervention’s delivery details and a specific definition or threshold for feasibility are also not reported in the registry record.

Safety information is limited to the listed counts and does not include further monitoring or event-collection detail. These limitations reflect what is not described in the registry record; they should not be taken as evidence that particular procedures or analyses were not performed. They do mean that the posted information is insufficient to independently assess the primary outcome analysis or draw conclusions about intervention effects.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Multicultural Healthy Diet in Chronic Kidney Disease — NCT05504850.
• Registry record last updated 2026-08-11; status last verified 2026-07.
• Results first posted 2026-08-11.
• 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

NCT05504850 is a completed, single-group pilot study sponsored by Montefiore Medical Center. It enrolled 18 participants with chronic kidney disease, and all participants received the Multicultural Health Diet intervention. The official title describes a culturally tailored anti-inflammatory dietary pattern for racial and ethnic minorities with chronic kidney disease. Allocation is listed as NA, masking as none, and phase as NA.

The primary outcome concerns feasibility from baseline before intervention to 2 months after intervention. The registry names the Automated Self-Administered 24-hour Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index, and specifies a mean with a 95% confidence interval. The numerical primary outcome results and an acceptability result are not reported in the registry record. Safety counts list 0 serious adverse events, 0 other adverse events, and 0 deaths among 18 participants at risk in the respective categories.