Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome (NCT03937960), a randomized na study. The primary outcome is Dyslipidemia Measures.

2. Clinical Question

The registry describes a two-arm, randomized trial in children with obesity and metabolic syndrome. Its stated intervention period was 8 weeks. In principle, a comparison of lipid measurements after the diets could address whether the groups had different lipid outcomes during that period. The available primary result instead reports HDL at baseline in each group and an unadjusted between-group comparison of those baseline values.

That distinction matters for the clinical question. Baseline measurements precede the dietary intervention and can describe the groups at trial entry. They do not show how HDL changed over the intervention or whether any change differed between diets. The posted result therefore informs readers about the baseline comparison, not the effect of either diet on dyslipidemia.

The registry record does not report a primary follow-up HDL result, a change-from-baseline analysis, or an adjusted treatment comparison. It also does not report the statistical plan for the trial. Consequently, the title and intervention descriptions set out the intended topic, while the posted outcome information determines what can be interpreted from the reported numbers.

3. Trial Design

The registry identifies NCT03937960 as a randomized, parallel-group trial. It lists the trial status as completed and the phase as NA. The record lists enrollment of 30 and describes randomization to two diet groups, with 15 children per group in the brief summary. The intervention period is described as 8 weeks. The listed age range is 10 to 18 years, and the study population is described as children with obesity and metabolic syndrome.

The comparison was between a carbohydrate-restricted diet and a standard low-fat diet. The carbohydrate-restricted diet description emphasizes limiting selected carbohydrate sources and includes a fixed carbohydrate amount and calorie goal. The low-fat diet description specifies a 55:25:20 percentage of energy from carbohydrate, protein, and fat, with reference to the USDA My Plate Daily Food Plan. The registry categorizes both interventions as other rather than assigning a drug-treatment category.

Masking is listed as none. That indicates the registry does not describe masking; it does not establish which people involved in the trial knew each participant's assigned diet. The record does not report details of allocation concealment, adherence measurement, co-interventions, or the handling of deviations from the assigned diets.

The primary measure and the posted secondary measures are all labeled as baseline outcomes. The primary measure is serum HDL concentration in mg/dL. Secondary measures include insulin resistance indices, body composition, and surrogate markers of vascular endothelial function. The registry lists 22 outcome measures and 7 posted secondary outcomes, but the posted secondary results include baseline comparisons rather than treatment-period results. No reported analyses are listed for the secondary outcomes, and the registry record does not report a trial analysis population or the disposition of participants after randomization.

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

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 Dyslipidemia Measures, measured over Baseline.

The primary outcome is titled “Dyslipidemia Measures.” Its description specifies baseline serum high-density lipoprotein concentration, measured in mg/dL, with the outcome expressed as a mean and standard deviation. HDL is one component of a lipid profile, so it can be used to describe lipid status in a population being studied for dyslipidemia. The registry record does not explain why this particular measurement was selected as the primary endpoint or provide a fuller rationale for its use.

The reported values are baseline means: 30.0 mg/dL in the standard low-fat diet group and 32.0 mg/dL in the carbohydrate-restricted group. The posted comparison is a mean difference of 2.0 mg/dL, with an unadjusted p-value of 0.006. Because the timeframe is baseline, this contrast describes the groups before the 8-week dietary intervention, rather than a difference in treatment response.

To evaluate an intervention effect, a result would need to describe an outcome measured after the intervention, a change from baseline, or an analysis that otherwise compares outcomes over the treatment period. Such a primary result is not reported in the registry record. Thus the baseline HDL result can be read as a description of initial group values, but it cannot answer whether either diet changed HDL or whether the diets differed in their effects.

7. Results Posted in the Registry

• Carbohydrate Restricted Group: mean 32.00 versus 30.00 on control; difference 2.00 (95% CI 0.57 to 3.43), standardized effect d = 1.00; z-test p = 0.006.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Insulin Resistance Indices

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Carbohydrate Restricted Group: mean 2.21 versus 2.15 on control; difference 0.06 (95% CI -0.04 to 0.16), standardized effect d = 0.42; z-test p = 0.245.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Carbohydrate Restricted Group and the control. The interval gives the range of effects that remain compatible with the data.

Body Composition

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Carbohydrate Restricted Group: mean 45.60 versus 43.20 on control; difference 2.40 (95% CI -1.44 to 6.24), standardized effect d = 0.45; z-test p = 0.221.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Carbohydrate Restricted Group and the control. The interval gives the range of effects that remain compatible with the data.

Surrogate Markers of Vascular Endothelial Function

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Carbohydrate Restricted Group: mean 11.20 versus 11.00 on control; difference 0.20 (95% CI -0.75 to 1.15), standardized effect d = 0.15; z-test p = 0.681.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Carbohydrate Restricted Group and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results follow the same timing pattern as the primary result: they are labeled baseline. They cover insulin resistance indices, body composition, and surrogate markers of vascular endothelial function. Their comparisons are descriptive contrasts between the randomized groups at trial entry, not reported changes during the dietary intervention.

Across the posted secondary measures, the estimates vary in direction and size, and their confidence intervals include zero. The unadjusted p-values do not indicate a clear set of baseline differences across these measures. This overall pattern does not resolve the primary clinical question because the secondary results also precede treatment and are not follow-up comparisons.

These measures are related to metabolic and vascular characteristics relevant to the population under study, but they do not replace the primary lipid outcome. Nor do baseline correlations or group contrasts establish that one diet changed insulin resistance, body composition, or vascular function. The record lists 22 outcome measures and 7 posted secondary outcomes, while the posted secondary results include only baseline measures. The registry record does not report analyses of secondary changes over the 8-week intervention.

Unadjusted secondary results carry less weight because multiple outcomes create more opportunities for apparently notable findings to arise by chance. General explanation: when many hypotheses are tested, considering each p-value without adjustment or a prespecified hierarchy can overstate the strength of evidence across the set. The registry record does not report a multiplicity adjustment, a testing hierarchy, or which secondary endpoints were prespecified for confirmatory inference.

Accordingly, the secondary results are best treated as baseline descriptions and exploratory context. They neither confirm a dietary effect nor provide a substitute estimate when the primary follow-up result is absent from the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Insulin Resistance Indices
• Body Composition
• Body Composition
• Surrogate Markers of Vascular Endothelial Function
• Surrogate Markers of Vascular Endothelial Function
• Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
• Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports continuous outcomes as means with standard deviations. A mean describes the average measurement in a group, while a standard deviation describes the spread of individual measurements around that average. These are descriptive summaries, not complete accounts of the individual data. The primary HDL outcome and the posted secondary outcomes use this mean-and-standard-deviation format.

What does the mean difference describe?

For the primary result, the mean difference compares the carbohydrate-restricted group with the standard low-fat diet group. The reported group means are 32.0 mg/dL and 30.0 mg/dL, respectively, and the posted difference is 2.0 mg/dL. The direction is therefore positive for the carbohydrate-restricted group in this baseline comparison. A mean difference is expressed in the measurement's original units, which makes it interpretable on the HDL scale.

The interpretation depends on when the measurements were taken. A comparison of baseline means describes starting values. A comparison of post-intervention means or of changes over time could address a treatment-period contrast, subject to the analysis approach. The registry record labels the primary measure as baseline and does not report those later analyses. The mathematical form of a mean difference alone does not make it a treatment effect.

What do the standard deviation and standard error represent?

A standard deviation describes variation among measurements within a group. A standard error describes uncertainty in an estimated group mean, given the sample and the model used. These quantities answer different questions: the standard deviation is about spread among observations, while the standard error is about precision of an estimate. The registry's primary outcome specifies standard deviation as the dispersion measure. The comparison details also list standard errors for the group means.

General explanation: standard errors are usually smaller when measurements are less variable or when a group contains more observations, assuming other aspects of the analysis remain comparable. Standard errors help determine the uncertainty around estimated means and contrasts, but do not indicate whether a difference is clinically important.

How should the confidence interval be read?

A confidence interval gives a range of values compatible with the data and the method used, under repeated use of that method and its assumptions. The primary interval for the mean difference is reported as 0.569 to 3.431 mg/dL. Its lower and upper limits are both positive. This interval quantifies uncertainty around the baseline contrast; it does not shift the measurement from baseline to follow-up or turn it into a treatment effect.

General explanation: an interval that includes zero is compatible with no difference under the corresponding model, while an interval that excludes zero indicates that zero is not among the values covered by that interval at its stated confidence level. The registry does not specify the confidence level in the outcome description, so the level should not be inferred from the record alone.

What does an unadjusted p-value mean?

The primary comparison has an unadjusted p-value of 0.006. In general, a p-value is calculated under a null hypothesis and a statistical model, and represents how unusual data at least as incompatible with that null would be if the model and null were correct. It is not the probability that a result occurred by chance, nor the probability that a treatment works. “Unadjusted” means the reported p-value is not described as adjusted for multiple comparisons. The registry record does not report the full test specification or analysis plan.

For this trial, the result tests or summarizes a baseline contrast, not an intervention effect. Statistical language should follow that timing: the posted baseline means differ in the unadjusted comparison; the result does not establish an effect of the diets. The record does not report adjustment for baseline values in a later analysis.

Why can over-dispersion matter?

General explanation: over-dispersion occurs when observed variability is greater than a model expects. It is especially relevant for count outcomes, where a simple model may underestimate variation and therefore overstate precision. The posted primary and secondary outcomes are continuous measures summarized by means and standard deviations, not count outcomes. The registry does not report an over-dispersion assessment or a model-based treatment analysis, so no claim about such an assessment can be made.

More broadly, the inferential meaning of a statistical result depends on the outcome timing, measurement, comparison, and assumptions. The posted primary result has a clear direction and a confidence interval excluding zero, but it is a baseline comparison. The registry record does not report a prospective analysis plan, a missing-data method, or the assumptions used for an intervention analysis. These omissions limit what can be inferred about how the trial was analyzed beyond the descriptive and comparison statistics posted.

11. Confidence Intervals and Precision

The primary baseline comparison is a mean difference of 2.0 mg/dL, with a reported confidence interval from 0.569 to 3.431 mg/dL. This interval lies above zero and gives a range of estimates compatible with the data and the method used for the comparison. It indicates uncertainty around the baseline group contrast, rather than uncertainty around a treatment effect.

Precision is distinct from importance. A relatively narrow interval can indicate that an estimate is more precisely located, but it does not establish that the difference matters clinically. A wider interval reflects greater uncertainty and can include a broader range of possible values. The registry record does not define a clinically important difference for HDL, so the clinical meaning of this baseline contrast is not reported.

The group standard deviations are 2.0 mg/dL in both arms. These describe observed spread in the reported baseline HDL values, whereas the confidence interval describes uncertainty in the estimated difference. Neither measure reveals the distribution of individual values in full, and the registry record does not provide individual-level data.

Confidence intervals only address the estimate to which they apply. Because the outcome timeframe is baseline, the interval cannot be interpreted as a range for the difference in HDL after 8 weeks or for a difference in change. The registry record does not report a follow-up estimate or its precision. The interval also does not account for uncertainty about unreported analysis choices, missing-data handling, or whether the posted comparison was prespecified.

Overall, the reported interval offers precision information about the baseline contrast. It should not be used to make claims about the magnitude or precision of an intervention effect that is not posted.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial's original design assumptions. The registry record does not report the assumptions used to choose the trial's enrollment. The posted planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning row uses the stated fraction of the observed effect as the effect to detect.

The figures are participants per arm, not total participants or total events. The 80% power column gives the estimated participants per arm for a design with an 80% probability of detecting the specified effect under the stated assumptions, if that effect and the model assumptions are correct. The 90% power column gives the corresponding planning estimate for a 90% probability. Higher planned power generally requires more participants when other assumptions remain the same.

The rows illustrate planning for 100%, 75%, and 50% of the observed effect. Smaller effects are harder to distinguish from random variation, so the planning figures require more participants as the effect becomes smaller. For the primary comparison, the figures range from 16 to 63 participants per arm for 80% power and from 22 to 85 participants per arm for 90% power across those effect assumptions.

These calculations are not observed power. They do not tell how likely the completed trial was to detect its true effect, and they should not be used to infer the probability that the reported result is correct. They are hypothetical planning estimates based on the observed baseline contrast, which is not a treatment-period effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 2.000; pooled standard deviation σ = 2.000.
2. n = 2 × (1.96 + 0.842)² × 2.000² / 2.000² = 15.7, rounded up to 16 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 2                      # observed difference in means
sigma <- 2                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3937960)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 16 (80% power), 22 (90% power)
 75% of observed effect: n per arm = 28 (80% power), 38 (90% power)
 50% of observed effect: n per arm = 63 (80% power), 85 (90% power)
power.t.test: 16.7 
Simulated power at n = 16 per arm: 0.784 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 22 outcome measures and 7 posted secondary outcomes. A collection of outcomes raises a multiplicity question: if many comparisons are examined, the chance of at least one small unadjusted p-value can increase. General explanation: multiplicity procedures or a prespecified hierarchy can help control how a family of tests is interpreted. The registry record does not report whether the trial used such a procedure, defined families of outcomes, or designated confirmatory and exploratory analyses.

The posted primary p-value is explicitly unadjusted. No adjustment method is reported for the secondary comparisons. This does not invalidate a descriptive comparison, but it means the results should not be treated as if the registry had established a multiplicity-controlled testing strategy. The record also does not report whether the posted outcomes or analysis choices were specified before data collection or analysis.

Missing-data handling is not reported in the registry record. The posted baseline group summaries list 15.0 observations per group, but the record does not explain whether all randomized participants contributed to each outcome, whether any measurements were missing, or how missing observations would have been handled in a follow-up analysis. It is therefore not possible to assess attrition, imputation, or sensitivity analyses from the posted information.

The analysis population is also not reported in the registry record. The record does not state whether the analysis followed an intention-to-treat principle, included only participants who completed the assigned diet, or used another population definition. It does not report protocol deviations, adherence-based exclusions, or per-protocol analyses.

The registry reports zero analyses and does not post a treatment-period primary comparison. It also does not report an interim-analysis plan, stopping rules, a detailed statistical analysis plan, or a sample-size justification for the original trial. These are unknowns, not evidence that any particular procedure was or was not used. Their absence limits evaluation of prespecification, analysis choices, and the robustness of any treatment-effect conclusion.

15. 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 5% reporting threshold.

The adverse-event record lists 15 participants at risk in each diet group for serious adverse events, with zero serious adverse events in both groups. It also lists zero deaths in both groups. The record lists 15 participants at risk for other adverse events in each group and zero affected for those events in both groups.

These figures describe what was recorded in the registry. They do not show that no adverse events could occur, and they do not establish that the diets have identical safety profiles. A zero count in a small trial can coexist with uncertainty about uncommon events or events that were not captured or reported. The registry does not list serious adverse-event terms, and the record does not provide detailed definitions, collection procedures, severity grading, or the duration of safety follow-up.

The safety figures should therefore be read as no serious adverse events, deaths, or other affected participants recorded in the posted groups, with the stated numbers at risk. They do not support a broader claim about safety beyond these registry results.

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

The posted results establish a limited statistical finding: at baseline, mean HDL concentration was 30.0 mg/dL in the standard low-fat diet group and 32.0 mg/dL in the carbohydrate-restricted group. The reported unadjusted mean difference was 2.0 mg/dL, with an unadjusted p-value of 0.006 and a confidence interval that excludes zero.

That finding is not a comparison of what the diets accomplished. Baseline measurements precede the intervention, so the contrast cannot be attributed to assignment to either diet. The registry record does not report post-intervention HDL values, changes from baseline, or an adjusted treatment comparison. It therefore does not establish whether HDL changed, whether the diets differed in their effects, or whether either diet affected dyslipidemia.

The same caution applies to the posted secondary measures. Their baseline comparisons describe the groups at entry; they do not show intervention-related changes in insulin resistance, body composition, or vascular-function measures. The unadjusted nature of the secondary comparisons and the absence of a reported multiplicity strategy further limit confirmatory interpretation.

Statistical significance is not the same as clinical importance. The registry record does not report a threshold for a clinically meaningful HDL difference, and the baseline result alone cannot be used to infer health benefits or harms. The absence of recorded adverse events is likewise limited to the posted safety data and does not establish that a diet is safe for an individual or population.

In short, the available numbers describe baseline group characteristics and recorded adverse events. They do not answer the treatment-effect question implied by the trial title. Conclusions about the effects of the diets would require results measured during or after the intervention and an interpretable analysis of those outcomes.

17. Why This Trial Matters Statistically

This trial illustrates why endpoint timing is as important as the name of an outcome. A primary measure can concern a clinically relevant biomarker, yet a baseline comparison cannot estimate an intervention effect. The primary result has a confidence interval excluding zero and an unadjusted p-value of 0.006, but those statistics apply to an initial group contrast. Statistical evidence does not overcome the mismatch between baseline timing and a treatment-effect question.

The distinction also clarifies the role of randomization. Random assignment is intended to support a fair comparison of outcomes after assignment, but it does not make every difference between groups a treatment effect. In a small randomized trial, baseline values can differ; describing such a difference is not the same as demonstrating that the intervention caused it. The registry record does not report a later analysis that accounts for baseline values or compares follow-up outcomes.

Planning estimates also need careful interpretation. The sample-size illustrations use fractions of the observed effect and stated statistical assumptions, but the observed estimate is a baseline difference rather than a reported intervention effect. Those illustrations can show how planned precision depends on the assumed effect size; they cannot recover an unreported original design rationale or establish the completed trial's power.

Finally, the registry record demonstrates the importance of complete outcome reporting. The intended 8-week dietary comparison is described, but follow-up primary and secondary analyses are not posted. Without those estimates, readers cannot assess treatment-period effects, their precision, or the role of missing data and analysis populations. Clear timing, prespecified outcomes, and complete reporting are essential for separating descriptive evidence from causal conclusions.

18. 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 interpretation is that the posted primary and secondary outcomes are labeled baseline. The registry record does not report a primary follow-up HDL result or treatment-period estimates for the secondary measures. Consequently, the outcome data do not address the intervention contrast described in the trial title.

The registry record also lists zero analyses. It does not report a statistical analysis plan, original sample-size justification, missing-data approach, analysis population, or multiplicity procedure. This means readers cannot determine from the record whether any later analyses were prespecified, how missing measurements were handled, or which comparisons were intended to be confirmatory.

The trial is described as involving 15 participants per group, and the posted measures are summarized using group means and standard deviations. Such summaries do not show individual observations, distributional features, adherence, or variation in response. The registry does not report allocation concealment, adherence results, or details of participant retention and follow-up.

The record lists no masking. It does not provide enough detail to assess how participants, study personnel, or outcome assessors were informed about assignment, or whether measurement procedures could have been influenced by knowledge of diet assignment. The registry also does not give detailed safety collection methods or follow-up beyond the event counts.

These limitations are specific to the information posted for this trial. They do not establish that unreported procedures were absent; rather, those procedures and results are not reported in the registry record. The lack of follow-up outcome results is especially consequential because it prevents assessment of the stated dietary comparison.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome — NCT03937960.
• Registry record last updated 2022-12-22; status last verified 2022-11.
• Results first posted 2022-12-22.
• 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.

22. Record Summary

NCT03937960 is listed as a completed, randomized, parallel-group trial comparing a carbohydrate-restricted diet with a standard low-fat diet in children aged 10 to 18 with obesity and metabolic syndrome. The brief summary describes an 8-week intervention and 15 participants per group. Masking is listed as none.

The posted primary outcome is baseline serum HDL concentration. The reported means are 30.0 mg/dL for the standard low-fat diet group and 32.0 mg/dL for the carbohydrate-restricted group; the unadjusted mean difference is 2.0 mg/dL, with an unadjusted p-value of 0.006. This is a baseline contrast, not a treatment-effect estimate. The registry record does not report a primary follow-up result or treatment-period analyses of the secondary outcomes.

The adverse-event record lists zero serious adverse events, deaths, and other affected participants in both groups. The registry record does not report the original sample-size rationale, analysis population, missing-data procedures, or multiplicity plan.