Role of Peanuts in Healthy Weight Gain in Athletic Individuals: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Role of Peanuts in Healthy Weight Gain in Athletic Individuals (NCT05426109), a randomized na study. The primary outcome is Change in Total Body Mass (Weight).

2. Clinical Question

The trial asks whether adding peanut-containing snacks, compared with peanut-free snacks, is associated with a different change in total body mass during a diet and supervised strength-training regimen intended to promote weight gain. The registry describes an additional 500 kcal/day from snacks in either group, over 10 weeks. The primary outcome is change in total body mass, measured in kilograms.

The contrast is between two snack approaches within a broader regimen, not between snacks and no added snacks. Both groups were assigned additional energy intake and supervised strength training. Consequently, any valid comparison would concern the difference between the assigned snack strategies under the trial conditions; it would not isolate the effect of peanuts from every other feature of the regimen. The posted registry information does not establish whether the two groups differed in weight change.

3. Trial Design

The registry describes a randomized, open-label, parallel-group trial. Participants were assigned to peanut-containing snacks or snacks without peanuts. In a parallel design, each participant is assigned to one study group, and the groups are compared. Random allocation can help balance participant characteristics across groups on average, although it does not guarantee balance in a small trial. The registry reports enrollment of 33. It does not report the number randomized, the number completing the regimen, or the number included in a primary outcome analysis.

Both groups were intended to receive an extra 500 kcal/day through daily snacks for 10 weeks, together with supervised strength training. The peanut group received peanut-based whole foods or snacks; the control group received a similar, high-carbohydrate, peanut-free snack. This active comparator makes the main question a comparison of snack composition and strategy against another snack strategy, rather than a comparison with no extra food.

The study is listed as having no masking. Participants and study personnel therefore were not described as blinded to group assignment. The registry record does not report whether outcome assessors were masked, how adherence was assessed, or whether the prescribed snack intake and training were achieved.

The primary outcome is change in total body mass. Weighing was scheduled at baseline and at the 3-wk, 7-wk, and 11-week test sessions, using a digital scale with standardized lab clothing. The registry describes the dietary and exercise regimen as 10 weeks, while the listed measurement schedule includes an 11-week session; the reason for that timing is not reported in the registry record. The study is marked completed, with start and primary-completion dates of 2021-11-22 and 2022-11-10. Completion status does not by itself indicate that results were posted.

The record lists three secondary outcomes: change in resting metabolic rate, testosterone levels, and insulin-like growth factor levels. It reports five outcome measures in total, but the names of the other outcome measures are not reported in the registry record. The phase is listed as NA.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Total Body Mass (Weight), measured over 1-min laboratory measurement assessed at the baseline, 3-wk, 7-wk, and 11-week test sessions..

The primary endpoint is change in total body mass, measured in kilograms. The registry says participants were weighed on a digital scale while wearing standardized lab clothes at scheduled test sessions. A body-mass measure is directly relevant to a study whose stated aim is to examine weight gain. Repeated measurements can describe the trajectory of weight across the study schedule, while a change measure can express how far body mass moved from the participant’s baseline value.

The record lists assessments at baseline, 3-wk, 7-wk, and 11-week test sessions. It does not state which follow-up time point defines the primary comparison, how change is calculated, or whether the primary contrast is a difference in change between groups, a comparison at a particular visit, or another summary. Those details are not reported in the registry record.

Body mass is not the same as lean mass. The trial summary describes interest in healthy gains, particularly lean mass, but the listed primary endpoint measures total body mass. The endpoint alone therefore cannot distinguish changes in lean tissue, fat tissue, fluid, or other contributors to body weight. The registry names additional outcomes related to resting metabolic rate and hormone levels, but their results are not reported in the registry record.

No primary endpoint values, group means, standard deviations, confidence intervals, or test results are posted. As a result, the recorded measurement plan can be described, but the size and precision of any weight change cannot be evaluated from the registry results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a mean of a continuous measure, with standard deviation as the dispersion summary. Total body mass in kilograms is continuous because it can take values across a measurement scale rather than belonging to a set of distinct categories. A mean gives the arithmetic center of the measured values in a group. A standard deviation describes how dispersed individual measurements are around that mean. It does not indicate uncertainty in the mean itself, and it does not describe the range of all individual values.

What would a group comparison describe?

In a randomized parallel-group trial, a between-group comparison addresses whether the measured outcome differs between participants assigned to the two snack strategies. For this study, a useful estimate would need to define the outcome time point or change summary and compare the groups on that same basis. A contrast in average weight change would describe the difference observed between the assigned groups under the analysis used. It would not, by itself, show why the groups differed or establish that snack composition was the only relevant influence.

The record lists several measurement occasions: baseline, 3-wk, 7-wk, and 11-week test sessions. Repeated measurements from the same participant are related, rather than independent observations. General statistical methods for repeated measures account for that within-person relationship and can use information across visits, depending on the chosen model and assumptions. A simple comparison at a single follow-up visit answers a different question from a comparison of change from baseline or a model of the entire trajectory. The registry record does not report which approach was used, or how the primary comparison was defined.

What does uncertainty mean?

General explanation: a confidence interval expresses uncertainty around an estimated effect under a specified statistical model and its assumptions. Its width is influenced by factors such as the amount of outcome information and variability among participants. A narrow interval indicates greater precision than a wide interval, but the interval still does not describe every individual participant’s experience. No confidence interval for the primary outcome is reported in the registry record.

A p-value, when reported, summarizes how compatible the observed data are with a specified null model, given the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A p-value cannot substitute for an estimate and its uncertainty. The registry lists no analyses, and no primary outcome p-value is reported.

Why can variability matter?

General explanation: dispersion matters because individual participants may vary in their response and in their measured outcome. Greater variability can make a group mean less precise when the amount of data is otherwise similar. The standard deviation is a description of participant-level spread, whereas the standard error describes uncertainty in an estimate. These quantities answer different questions and should not be used interchangeably. The record identifies standard deviation as the planned dispersion summary, but does not report its value for either group.

In some data, variability is greater than a statistical model expects. This is called over-dispersion. General explanation: if a model assumes less variability than is actually present, standard errors may be too small and confidence intervals may be too narrow. That concern depends on the outcome and model. The registry record does not describe an analysis model, an over-dispersion assessment, or a model adjustment, so none can be attributed to this trial.

What can randomization and masking contribute?

Random allocation is intended to make assignment independent of participant characteristics before treatment begins. In expectation, this supports fair comparison, but chance imbalance can remain, particularly when a study is small. Statistical adjustment may sometimes address prespecified prognostic characteristics, but the registry does not report whether any adjustment was planned or used. Open-label assignment means that masking is listed as none. General explanation: awareness of assignment can influence behaviors, co-interventions, or reporting, although the extent depends on the study and outcome. The registry does not report whether assessors were masked or whether such effects occurred.

How should planning calculations be read?

The registry’s sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The stated effect to detect is a fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial was designed with that target. The numerical planning results and the trial’s own sample-size justification are not reported in the registry record. A sample-size calculation depends on assumptions about the target effect, outcome variability, allocation, and analysis; uncertainty in those assumptions can affect the resulting target. It does not replace reporting the actual estimate and its uncertainty.

Because primary outcome results and analysis methods are absent, these concepts explain how such results could be interpreted, not what analysis was conducted in this trial. The registry record does not report the model, covariates, estimand, test, or multiplicity procedure used for the primary outcome.

10. Multiplicity, Missing Data and Analysis Populations

The record lists five outcome measures, including the primary outcome and three named secondary outcomes: change in resting metabolic rate, testosterone levels, and insulin-like growth factor levels. The remaining outcome measure names are not reported in the registry record. It also lists no analyses. The registry record does not report a statistical analysis plan, an outcome hierarchy beyond identifying the primary endpoint, or a procedure for handling multiple comparisons.

General explanation: when many outcomes, time points, or subgroup comparisons are examined, the chance of obtaining a seemingly notable result by chance can increase. Multiplicity procedures can control that risk, while a prespecified hierarchy can clarify which comparisons are confirmatory and which are exploratory. The relevant issue depends on how many tests were actually planned and performed. That information is not reported in the registry record, so the multiplicity strategy cannot be evaluated.

The primary outcome is measured at several scheduled sessions, but the record does not specify which follow-up comparison is primary. It also does not report the number of participants with measurements at each session, reasons for missing measurements, or methods for handling missing data. Missing outcome information can affect the estimate and its uncertainty, particularly if the chance of a missing measurement is related to the outcome or group assignment. General statistical approaches make different assumptions about those relationships; the registry does not identify an approach used in this trial.

The analysis population is also not reported in the registry record. It is therefore not possible to determine whether the primary analysis included all randomized participants, only participants with available measurements, or another defined group. The enrollment count should not be interpreted as the number contributing to every outcome analysis.

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 16 participants at risk in each group. For Peanut Snacks and No Peanut-containing Snacks, it reports 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the figures recorded for the listed at-risk participants. The registry record does not provide event terms, and no top serious adverse-event terms are listed.

These counts are descriptive safety information, not a comparison of the primary weight outcome. A recorded count of zero means no events of that category were reported in the registry data for the stated group; it does not establish that the underlying risk is zero. The figures also do not describe event severity beyond the serious-versus-other categories, timing, duration, or a formal statistical comparison.

The registry reports enrollment of 33, whereas the at-risk counts are 16 in each group. It does not explain the relationship between these numbers. The at-risk counts should not be assumed to represent all enrolled participants or the primary outcome analysis population. The record does not report the method for collecting adverse events, the period of safety surveillance, or how missing safety information was handled. Accordingly, these figures should be read narrowly as the posted event counts, not as evidence that the intervention is free of risk.

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

The trial addresses a practical research question: whether two approaches to adding energy through snacks differ in their association with body-mass change when used alongside supervised strength training. Both groups were assigned an extra 500 kcal/day of snacks for 10 weeks. The registry identifies peanut-containing snacks as the intervention and peanut-free, high-carbohydrate snacks as the comparator. This design is relevant to comparing those snack approaches within the described regimen.

The record does not report the primary outcome results. It therefore cannot establish the direction or size of any difference in total body mass between groups, or how precisely that difference was estimated. Completion status, the planned measurement schedule, and adverse-event counts do not fill that gap. In particular, the safety record’s zero event counts do not provide evidence about weight change.

Even with results, total body mass would not on its own show whether any change consisted of lean mass or another component of body weight. The study summary emphasizes interest in healthy weight gain, but the listed primary endpoint is total body mass. The registry lists other physiological outcomes, but their results are not reported in the registry record.

The comparison also should be interpreted as a contrast between two snack strategies, not as a test of adding snacks versus not adding snacks. Both groups were intended to receive extra energy and supervised strength training. Any estimated group contrast would be specific to the study conditions and the participants enrolled; the registry does not provide enough detail to assess how broadly results might apply to other populations.

The record describes the trial’s question, randomization, masking, regimen, measurement schedule, and safety counts. It does not report a statistical analysis plan, outcome estimates, or missing-data methods. Thus, the registry information can explain what the study set out to compare, but not whether the groups’ body-mass changes differed or whether any difference was important.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it compares two active snack strategies within a weight-gain regimen. Both groups were intended to receive an extra 500 kcal/day, and both were included in a supervised strength-training program. That design focuses attention on the contrast between the assigned snack approaches rather than on the effect of adding snacks against no added snacks. Understanding the contrast requires a clearly defined outcome comparison and complete reporting of the observed data.

The repeated body-mass measurements offer a potential way to describe change over time, but analysis depends on how the visits are used. A comparison at a specific visit, a baseline-adjusted follow-up comparison, and a model of the measurement trajectory can answer related but distinct questions. The registry reports the measurement schedule but not the selected primary comparison or analysis model. This makes the design understandable while leaving the statistical interpretation of any result unresolved.

The registry also illustrates why outcome reporting and design information are not substitutes for one another. Randomization is important for the intended comparison, and the record identifies the study as randomized. Yet without group estimates and measures of uncertainty, readers cannot assess the size or precision of the primary effect. Likewise, a completed study and recorded safety counts do not establish an efficacy result.

Finally, the distinction between total body mass and lean mass is important to the stated motivation. The primary endpoint directly measures body mass, not body composition. This difference affects what a future analysis could support: a weight-change result would describe total mass, while a claim about its composition would require relevant measurements and results. Those results 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.

The main limitation for statistical interpretation is the absence of primary outcome results. The record does not report group means, standard deviations, the between-group estimate, confidence intervals, or a p-value for change in total body mass. It is therefore not possible to assess the direction, magnitude, or precision of the primary comparison.

The primary comparison is not fully specified in the registry record. Although measurements are listed at baseline and follow-up sessions, the record does not identify which follow-up or change summary is the primary analysis. The listed intervention period is 10 weeks, while the measurement schedule includes an 11-week session; the reason for this timing is not reported in the registry record.

The record reports enrollment of 33 but does not report the number randomized, the number completing the regimen, or the number included in each outcome analysis. The adverse-event record lists 16 participants at risk in each group, but the registry does not explain how those counts relate to enrollment. Participant flow, adherence, withdrawals, and reasons for missing outcome measurements are not reported in the registry record.

The trial is listed as open-label. The record does not say whether outcome assessors were masked, whether the assigned snack strategies were followed, or whether any departures from the intended regimen occurred. It also does not report the statistical model, covariate adjustment, multiplicity handling, or analysis population.

Total body mass does not distinguish lean mass from other components of weight. The registry’s summary describes an interest in healthy weight gain, but the primary measure alone cannot characterize body composition. The extent to which the results would generalize beyond the enrolled athletic individuals is also difficult to assess because the registry does not provide a detailed description of the primary outcome population.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Role of Peanuts in Healthy Weight Gain in Athletic Individuals — NCT05426109.
• Registry record last updated 2025-06-10; status last verified 2025-05.
• Results first posted 2025-06-10.
• 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

NCT05426109 is a completed, randomized, open-label, parallel-group study sponsored by Virginia Polytechnic Institute and State University. The registry reports enrollment of 33 and compares peanut-containing snacks with snacks without peanuts or peanut-containing foods. Both groups were intended to receive an extra 500 kcal/day for 10 weeks alongside supervised strength training.

The primary outcome is change in total body mass in kilograms, with measurements scheduled at baseline, 3-wk, 7-wk, and 11-week test sessions. The record lists three secondary outcomes concerning resting metabolic rate, testosterone, and insulin-like growth factor. It reports no analyses. Primary outcome estimates, analysis methods, missing-data handling, and the analysis population are not reported in the registry record.

The adverse-event record lists 16 participants at risk in each group and reports 0 serious adverse events, 0 other adverse events, and 0 deaths in both groups. These counts do not establish the primary outcome result or the absence of risk.