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 Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes (NCT03758742), a na na study. The primary outcome is Diabetes Remission Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03758742 |
| Phase | NA |
| Condition | Diabetes Mellitus, Type 2 |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Alabama at Birmingham |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns adults with type 2 diabetes. The registry describes the feeding trial as intended for weight-stable adults; its primary outcome was analyzed per protocol among completers who met a specified weight-stability criterion. The enrollment was 34, but the number of participants included in the primary outcome analysis is not reported in the registry record.
Intervention
Participants received a supervised, controlled feeding intervention described as a high-fruit diet. The diet description specifies that approximately 50% of calories came from whole fruit. The study summary describes a 12-week dietary intervention. The registry record does not report adherence results or the amount of fruit actually consumed by participants.
Comparator
There was no separate comparison group in this single-group study. The outcome timeframe is change from baseline to week 12, so the comparison is within the same study group over time rather than between a fruit-rich diet and a concurrent control diet. The record does not describe a randomized allocation.
Primary question
The primary outcome is the diabetes remission rate, described as the percentage maintaining non-diabetic levels of 24-hour mean glucose without pharmacotherapy at week 12. The statistical question is how many participants met that outcome under the study’s per-protocol analysis, and how precisely that proportion was estimated. The outcome value and its uncertainty are not reported in the registry record, so the question cannot be answered from the registered results alone.
3. Trial Design
This was a completed, single-group behavioral feeding trial sponsored by the University of Alabama at Birmingham. The registry lists enrollment of 34 and gives the study dates as 2019-09-10 for start and 2023-09-05 for primary completion. The trial is listed as phase NA. Allocation is listed as NA, masking as none, and the study model as single group. These details describe a design without a randomized concurrent control group and without masking.
The study summary describes supervised controlled feeding of a whole-fruit-rich diet for 12 weeks in weight-stable adults with type 2 diabetes. The intervention description says that approximately 50% of calories came from whole fruit. The primary outcome timeframe is change from baseline to week 12. A before-and-after comparison can describe what changed during the study period, but without a separate comparison group it cannot distinguish changes associated with the intervention from changes that might have occurred over time for other reasons.
The primary outcome was analyzed per protocol in completers who met the specified weight-stability criterion. The number of participants meeting those analysis conditions is not reported in the registry record. The registry lists secondary outcomes concerning insulin sensitivity, beta-cell responsivity, insulin and C-peptide during an oral glucose tolerance test, glycemic excursions from continuous glucose monitoring, fasting glucose, and HbA1c. Outcome values for these measures 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.
Overall Study
| Stage | High-Fruit Diet |
|---|---|
| STARTED | 34 |
| COMPLETED | 12 |
| NOT COMPLETED | 22 |
Analysis population for the primary outcome, as defined in the registry: Results were analyzed per-protocol in completers who met the specified weight stability criterion
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: Results were analyzed only per-protocol, as is the norm for controlled feeding trials. In our study, per-protocol was defined as (a) completing the study with \>=80% adherence and (b) meeting the weight stability criterion. Twelve participants completed the study, and of these, ten also met the weight stability criterion.
| Characteristic | Unit | High-Fruit Diet |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 56 (SD 8) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 2 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Diabetes Remission Rate, measured over Change from baseline to week 12.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Diabetes Remission Rate and is measured as a count of participants. Its description defines the target outcome as the percentage of patients who maintain non-diabetic levels of 24-hour mean glucose without pharmacotherapy at week 12. The timeframe is change from baseline to week 12. Thus, the endpoint combines a glycemic criterion with medication status: meeting the stated glucose criterion while not using pharmacotherapy is central to the registry’s definition.
The study summary explains that medication-dose changes can skew interpretation of glycemic outcomes. A criterion that requires non-diabetic glycemia without pharmacotherapy is intended to distinguish that outcome from glucose levels achieved while taking glucose-lowering medication. This is a rationale for the endpoint, not evidence that any participant met it. The exact threshold used to classify 24-hour mean glucose as non-diabetic is not reported in the registry record.
The registry calls the outcome a rate, but lists its measure as a participant count. To interpret a rate, readers need both the number meeting the criterion and the number assessed under the analysis definition. Neither the remission count nor the primary analysis denominator is reported in the registry record. The endpoint’s value and precision therefore cannot be interpreted from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its analysis population, but does not report the primary outcome result. It gives no remission count or percentage, no analysis denominator, and no confidence interval or other uncertainty estimate. Accordingly, the posted record does not establish the observed remission rate or how precisely that rate was estimated.
The enrollment of 34 is not necessarily the denominator for the primary analysis. The record says that primary results were analyzed per protocol in completers meeting a weight-stability criterion, but does not report how many participants met those conditions. It would therefore be incorrect to treat enrollment as the number assessed or to calculate a percentage using enrollment as a denominator.
The study has a single group and compares the endpoint timeframe with baseline. Such a design can describe change within the group, if the relevant measurements and analysis results are reported. It does not provide a concurrent control group against which to compare that change. Even a measured improvement from baseline would not, on its own, identify the diet as the cause; other influences over the study period cannot be separated by a between-group comparison in this design.
The registry describes the primary outcome as remission based on non-diabetic 24-hour mean glucose without pharmacotherapy at week 12. That definition should not be broadened to mean remission under other glucose measures or medication conditions. The exact glucose threshold is not reported in the registry record. The record also does not report how medication changes were handled beyond the medication-free element in the outcome description.
There are no reported estimates for the listed secondary outcomes in the registry record. Their presence as named outcomes does not establish whether they changed, in which direction, or with what precision. No significance test or interval estimate for the primary result is reported, so the evidence cannot be characterized by a p-value or a statistical uncertainty range from this record. The appropriate reading is that the registry describes a planned and completed single-group study and defines its primary outcome, while the results needed to quantify that outcome are not reported.
9. Statistical Methods Explained
The registry describes a participant-count outcome, analyzed per protocol, in a single-group study with a baseline-to-week-12 timeframe. These details determine what statistical interpretation is possible. The record does not report the remission count, the analysis denominator, or an effect estimate, so explanations of methods must be separated from claims about results.
What does a participant-count endpoint represent?
For a binary endpoint such as meeting or not meeting a remission definition, each assessed participant is classified into one of those outcome categories. A count reports how many meet the criterion; a rate or proportion relates that count to the number assessed. The denominator matters because a count alone does not show how common the outcome was among those analyzed. Here, the registry describes the endpoint as a participant count and as a percentage, but does not report either the remission count or the denominator used for the per-protocol analysis.
In general, a confidence interval expresses the uncertainty around an estimated proportion under a statistical model. It does not guarantee that the true value lies within a particular interval, and its width depends in part on the amount and pattern of available information. No interval for this endpoint is reported in the registry record. Without the outcome count and denominator, the observed proportion and its precision cannot be reconstructed.
What can a baseline-to-follow-up analysis show?
General statistical interpretation: a within-group comparison describes how outcomes differ between baseline and follow-up among the participants included in an analysis. It can be useful for describing observed change. However, without a concurrent control group, it cannot separate a possible intervention effect from other changes over time, including changes in care, behavior, measurement conditions, or chance variation. The registry gives the endpoint timeframe as change from baseline to week 12, but does not report the measurements or the analysis used to quantify change.
The remission endpoint has an additional distinction: the criterion includes being without pharmacotherapy. Changes in medication can affect glycemic measurements and their interpretation. The study summary gives this as a reason for assessing glycemic control hierarchically. The registry record does not provide enough detail to describe the full hierarchy or how medication changes were incorporated into analyses beyond the stated medication-free endpoint definition.
What do the planning assumptions mean?
The record characterizes its sample-size assumptions as a planning illustration based on the observed effect, rather than the trial’s own design. It describes a two-sided significance level of 0.05, equal allocation between two hypothetical arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Those assumptions do not describe the registered study, which is single group and has no randomized allocation. Planning calculations under a hypothetical two-arm design should not be interpreted as the actual allocation or analysis of this trial.
In general, a sample-size calculation asks how much information a planned design might need to detect a specified effect under stated assumptions. It is a forward-looking planning exercise, not a measure of what the trial observed. The record explicitly characterizes these calculations as illustrations, not as the trial’s own design. Such figures are not observed power and do not establish that an effect was detected. The observed primary effect needed to understand the stated fractional-effect scenarios is not reported in the registry record, nor are numerical planning results included in the record.
What is not established about the statistical analysis?
The registry record does not report a statistical analysis plan, a test used for the primary outcome, a confidence-interval method, or adjustments for potential confounding. It does not report whether a model was used or how deviations from any model assumptions were assessed. These omissions matter because different methods can produce different estimates of uncertainty, especially when outcomes are binary and the number analyzed is limited. General statistical practice is to interpret estimates alongside the method and its assumptions; those details are unavailable for the primary result in this record.
The record lists 34 outcome measures and one analysis, but does not give their statistical results or explain the analysis structure. The existence of an analysis count does not identify the estimator, test, or adjustment strategy. The listed secondary outcomes also concern different measurements and biological processes; their names alone do not show which were measured successfully or how they were analyzed. No unreported test, model, or precision measure should be inferred from the endpoint labels.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and several secondary outcomes, but does not report whether statistical testing across outcomes was adjusted for multiplicity. It also does not describe a prespecified testing sequence or provide a statistical analysis plan. The study summary says glycemic control would be assessed hierarchically, in descending order of importance, because medication-dose changes can affect interpretation. However, the record does not give the full hierarchy or explain how the hierarchy governed statistical testing. The presence of multiple outcomes means that isolated statistical findings, if reported elsewhere, would need to be interpreted in light of the analysis strategy; that strategy is not reported in the registry record.
The primary outcome population is described as per-protocol completers who met the specified weight-stability criterion. The number analyzed is not reported. The record does not describe missing-data handling, reasons for non-completion, or whether participants with unavailable measurements were excluded or otherwise handled. It therefore does not allow assessment of how missingness may have affected the primary estimate.
The registry’s per-protocol description identifies a restricted analysis population, but does not report an intention-to-treat analysis or another analysis population. It is not possible to determine from the record whether results differed across populations or whether all enrolled participants contributed to the endpoint. The enrollment figure should not be substituted for an unreported analysis denominator.
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-Fruit Diet | 0 | 34 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| High-Fruit Diet | 0 of 34 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 4% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| High-Fruit Diet | 18 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | High-Fruit Diet |
|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | 18 of 34 |
| Hyperglycemia | Metabolism and nutrition disorders | 15 of 34 |
| Mild Stomach Pain | Gastrointestinal disorders | 4 of 34 |
| Mild Tremor | Nervous system disorders | 3 of 34 |
| Nausea | Gastrointestinal disorders | 3 of 34 |
| Dizziness | Nervous system disorders | 3 of 34 |
| Fatigue | General disorders | 2 of 34 |
| Diarrhea | Gastrointestinal disorders | 2 of 34 |
| Peripheral Sensory Neuropathy | Nervous system disorders | 2 of 34 |
The adverse-event record lists the High-Fruit Diet group with 34 participants at risk for serious adverse events and 34 at risk for other adverse events. It records zero serious adverse events and 18 participants with an event in the other-adverse-event category. No serious-event terms are listed. These are descriptive counts in a single study group, not comparisons against another diet or control group.
The counts do not establish whether the diet caused or prevented any event. The registry record does not describe the other events, their severity, timing, duration, or relationship to the intervention. A zero in the serious-event count means that none are recorded for this group in this record; it does not rule out risks that were not observed or recorded. The safety counts also do not replace the missing information about the primary glycemic outcome. Without a concurrent comparison group and fuller event descriptions, the figures support only a limited description of what the registry lists.
12. What the Result Does, and Does Not, Mean
The record provides a description of a completed supervised feeding study in adults with type 2 diabetes, including the dietary intervention, its single-group design, and the definition of the primary endpoint. It also reports adverse-event counts. It does not report the primary remission result, the number analyzed for that endpoint, or an estimate of uncertainty. The central glycemic result therefore cannot be quantified from the registry record.
The endpoint is specific: it concerns non-diabetic levels of 24-hour mean glucose without pharmacotherapy at week 12. It is not interchangeable with a result based on a different glucose measure, a different time point, or measurements while taking medication. The exact non-diabetic threshold is not reported. The endpoint’s name and definition describe what was assessed, not the outcome participants achieved.
The single-group design means that any baseline-to-week-12 change would be a within-group observation, not a direct comparison with a control diet. Even if a numerical change were reported, it would not by itself establish that the intervention caused the change. The registry record also does not report results for the listed secondary measures, so no conclusion about their direction or size is supported by the available results.
These limitations do not mean that the study has no statistical value. A carefully defined endpoint in a supervised feeding study can address a focused research question. But interpretation depends on the actual outcome values, analysis denominator, and uncertainty estimates, as well as on the design. Since those primary-result details are not reported in the registry record, the record supports describing the research question and design, not drawing a conclusion about the size or reliability of a glycemic effect.
13. Why This Trial Matters Statistically
This trial is statistically notable for asking a focused dietary question while using a single-group design. The registered intervention is a whole-fruit-rich diet, and the primary outcome combines a glycemic criterion with medication status. That definition makes the outcome more specific than a general statement about blood sugar, but it also makes clear operational details important, including the threshold for non-diabetic 24-hour mean glucose and the number of participants meeting the criterion. Those details are not reported in the registry record.
The design distinction matters because a baseline-to-follow-up comparison and a comparison between intervention and control groups answer different questions. A single-group study can describe what was observed over the study period. It cannot estimate a between-group difference or isolate the intervention from all other influences over time. Keeping that distinction explicit prevents descriptive changes from being mistaken for a controlled estimate of treatment effect.
The per-protocol analysis adds another interpretive consideration. The registry identifies completers who met a weight-stability criterion as the primary analysis population, but does not report how many participants qualified. This means the enrollment figure cannot stand in for the primary analysis denominator. Missing denominator and outcome information limit assessment of both the estimate and its precision.
Finally, the record illustrates the difference between a study’s outcome definition and its reported result. It names the primary endpoint and lists secondary measures, yet does not report their values. Statistical interpretation requires results and uncertainty, not just a question and a measurement plan. That distinction is useful when reading registry records: the design can be described even when the data needed to evaluate the measured effect are not reported.
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 primary limitation for interpreting results is that the registry record does not report the primary outcome value. It also does not report the remission count, the number included in the per-protocol analysis, or an uncertainty estimate. The enrollment of 34 therefore cannot be treated as the primary endpoint denominator. Without these elements, neither the remission proportion nor its precision can be assessed.
The single-group design has no concurrent control group. The registered baseline-to-week-12 timeframe permits a within-group description if measurements are available, but cannot by itself separate intervention-associated change from other time-related influences. The record’s allocation field is NA and its model is single group; it does not describe random allocation.
The registry describes analysis among completers meeting a weight-stability criterion but does not report how many met the criterion, reasons for non-completion, or missing-data methods. It also does not report adherence to the diet, medication changes during the study, or the specific threshold defining non-diabetic 24-hour mean glucose. Those omissions limit assessment of how closely the analyzed outcome represents the stated endpoint and intended intervention.
Additional limitations include the absence of reported results for the named secondary outcomes and the lack of reported multiplicity procedures or a statistical analysis plan. The record does not provide details of the primary statistical test or uncertainty method. These limitations are specific to interpreting this registered study; they do not establish that analyses or measurements were not conducted, only that those details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Whole Fruit on Glycemic Control in Adults With Type 2 Diabetes — NCT03758742.
- Registry record last updated 2025-06-10; status last verified 2025-05.
- Results first posted 2025-05-23.
- 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 University of Alabama at Birmingham sponsored this completed, single-group behavioral feeding trial in adults with type 2 diabetes. The registry lists enrollment of 34, no masking, and an intervention described as a whole-fruit-rich diet with approximately 50% of calories from whole fruit. The study summary describes supervised feeding for 12 weeks.
The primary outcome is diabetes remission, defined as maintaining non-diabetic levels of 24-hour mean glucose without pharmacotherapy at week 12. Primary results were analyzed per protocol in completers meeting a weight-stability criterion. The remission count, analysis denominator, and uncertainty estimate are not reported in the registry record. Serious adverse events are recorded as zero, and 18 participants are listed with an event in the other-adverse-event category. The design and reported counts can be described, but the primary glycemic result cannot be quantified from this record.